MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CLEARVIEW HCG DEVICE URINE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-102

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 - date of event- was not provided therefore a date of 1dec2023 was selected.G2 - report source - other was selected as the initial reporter is not a healthcare professional.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded valid negative results.No false positive results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.H3 other text : device return is not anticipated.

Event Description

The customer reported receiving a false positive hcg result while using the clearview hcg test.The patient presented to the hospital for an unknown planned surgery.As a result of the false positive hcg result, the surgery was cancelled.A confirmatory blood test was performed which later confirmed the patient was not pregnant.No further information was provided.

Manufacturer Narrative

B3 - date of event- was not provided therefore a date of (b)(6) 2023 was selected.G2 - report source - other was selected as the initial reporter is not a healthcare professional.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded valid negative results.No false positive results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.Per the package insert: positive results from very early pregnancy may later prove negative due to natural termination of the pregnancy.It is therefore recommended that weak positive results are re-tested 48-72 hours later with a first morning urine sample.Concentrations of hcg are generally lower in ectopic pregnancy than expected normal values for a given gestational age.Abnormal pregnancy cannot be distinguished from normal pregnancy by hcg levels alone.Hcg remains elevated for a time after pregnancy.Pregnancy tests carried out less than 3 weeks after giving birth or 9 weeks after natural loss or termination may need further evaluation.A number of conditions other than pregnancy can cause elevated levels of urinary hcg e.G.Menopause, trophoblastic disease and certain non-trophoblastic neoplasms.Drugs containing hcg may interfere with clearview¿ hcg cassette (25 miu/ml), and produce misleading results.False positive and false negative pregnancy tests may be observed in patients with abnormal bladder or kidney function e.G.Enterocystoplasties and renal failure.If the test result with clearview¿ hcg cassette (25 miu/ml) is not consistent with clinical evidence, further evaluation may be required.Concentrations of hcg greater than 500,000 miu/ml may elicit a prozone effect.Clearview¿ hcg cassette (25 miu/ml) is not validated for use with samples containing preservatives.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.H3 other text : device return is not anticipated.

Event Description

The customer reported receiving a false positive hcg result while using the clearview hcg test.The patient presented to the hospital for an unknown planned surgery.As a result of the false positive hcg result, the surgery was cancelled.A confirmatory blood test was performed which later confirmed the patient was not pregnant.No further information was provided.

Manufacturer Narrative

B3 - date of event- was not provided therefore a date of 1dec2023 was selected.G2 - report source - other was selected as the initial reporter is not a healthcare professional.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded valid negative results.No false positive results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.Per the package insert: -positive results from very early pregnancy may later prove negative due to natural termination of the pregnancy.It is therefore recommended that weak positive results are re-tested 48-72 hours later with a first morning urine sample.- concentrations of hcg are generally lower in ectopic pregnancy than expected normal values for a given gestational age.Abnormal pregnancy cannot be distinguished from normal pregnancy by hcg levels alone.- hcg remains elevated for a time after pregnancy.Pregnancy tests carried out less than 3 weeks after giving birth or 9 weeks after natural loss or termination may need further evaluation.- a number of conditions other than pregnancy can cause elevated levels of urinary hcg e.G.Menopause, trophoblastic disease and certain non-trophoblastic neoplasms.- drugs containing hcg may interfere with clearview¿ hcg cassette (25 miu/ml), and produce misleading results.- false positive and false negative pregnancy tests may be observed in patients with abnormal bladder or kidney function e.G.Enterocystoplasties and renal failure.- if the test result with clearview¿ hcg cassette (25 miu/ml) is not consistent with clinical evidence, further evaluation may be required.- concentrations of hcg greater than 500,000 miu/ml may elicit a prozone effect.- clearview¿ hcg cassette (25 miu/ml) is not validated for use with samples containing preservatives.- this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.B5 - describe event or problem: b5 has been updated to indicate alere san diego is not the legal manufacturer and the prior emdrs submitted by alere san diego for this event were submitted in error.H3 other text : device return is not anticipated.

Event Description

Upon further review, it was determined the legal manufacturer of the reported device, clearviewtm hcg cassette (25 miu/ml), is abon biopharm (hangzhou) co., ltd., instead of alere san diego, inc.Clearviewtm hcg cassette (25 miu/ml) is same/similar to hcg one step pregnancy device urine marketed in the us under 510(k) k993317.Therefore the two prior emdrs (2027969-2024-00007 and 2027969-2024-00007-01) were submitted in error.Abon biopharm (hangzhou) co., ltd is submitting mdr 3005641941-2024-00001-00 as they are the legal manufacturer for this event.The customer reported receiving a false positive hcg result while using the clearview hcg test.The patient presented to the hospital for an unknown planned surgery.As a result of the false positive hcg result, the surgery was cancelled.A confirmatory blood test was performed which later confirmed the patient was not pregnant.No further information was provided.

• Brand Name: CLEARVIEW HCG DEVICE URINE
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 18451330
• MDR Text Key: 332303241
• Report Number: 2027969-2024-00007
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 06952999404311
• UDI-Public: (01)06952999404311(17)250623(10)0000743558
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Catalogue Number: CV506788C
• Device Lot Number: 0000743558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female