MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. SURE-VUE SERUM/URINE HCG-STAT; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-A202

Device Problem False Positive Result (1227)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: retained devices from the reported lot numbers were tested with hcg-negative clinical urine and serum samples.The results were read at 3 and 4 minutes for urine, and 5 and 6 minutes for serum, and all devices yielded the expected negative results.Retained devices were also tested with qc cut-off urine (20 miu/ml) and serum (10 miu/ml) samples.The results were read at 3 minutes for urine and 5 minutes for serum, and all devices yielded the expected positive results.All results met final release specifications for line intensity.No false 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 lots 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: very low levels of hcg (less than 50miu/ml) are present in urine and serum specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning serum or urine specimen collected 48 hours later.A number of conditions other than pregnancy, including trophoblastic disease and certain nontrophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.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.

Event Description

The customer reported false positive results when testing urine and serum samples from one patient with the sure-vue serum/urine hcg-stat.The patient was being screened prior to a colonoscopy.The initial urine test yielded a faint test line and was interpreted as positive.The urine sample was retested, however the result was not specified.A serum sample was then collected and tested with the sure-vue serum/urine hcg-stat, yielding a similar faint positive result.Finally, a quantitative beta hcg test was performed with a result of 3 u/l, and the patient was determined not to be pregnant.The colonoscopy was delayed by approximately an hour and a half.No adverse outcomes were reported.Additional testing was performed the following day with an alternate lot and yielded similar results.See h-10 for the related report number.

Event Description

The customer reported false positive results when testing urine and serum samples from one patient with the sure-vue serum/urine hcg-stat.The patient was being screened prior to a colonoscopy.The initial urine test yielded a faint test line and was interpreted as positive.The urine sample was retested, however the result was not specified.A serum sample was then collected and tested with the sure-vue serum/urine hcg-stat, yielding a similar faint positive result.Finally, a quantitative beta hcg test was performed with a result of 3 u/l, and the patient was determined not to be pregnant.The colonoscopy was delayed by approximately an hour and a half.No adverse outcomes were reported.Additional testing was performed the following day with an alternate lot and yielded similar results.

Manufacturer Narrative

A3a - sex corrected to female.B3 and b6 updated to correct date of occurrence investigation conclusion: retained devices from the reported lot numbers were tested with hcg-negative clinical urine and serum samples.The results were read at 3 and 4 minutes for urine, and 5 and 6 minutes for serum, and all devices yielded the expected negative results.Retained devices were also tested with qc cut-off urine (20 miu/ml) and serum (10 miu/ml) samples.The results were read at 3 minutes for urine and 5 minutes for serum, and all devices yielded the expected positive results.All results met final release specifications for line intensity.No false 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 lots 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: ¿ very low levels of hcg (less than 50miu/ml) are present in urine and serum specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning serum or urine specimen collected 48 hours later.¿ a number of conditions other than pregnancy, including trophoblastic disease and certain nontrophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.¿ as with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.¿ 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.

• Brand Name: SURE-VUE SERUM/URINE HCG-STAT
• 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: 19177524
• MDR Text Key: 341016165
• Report Number: 2027969-2024-00048
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00613647000571
• UDI-Public: (01)00613647000571(17)250315(10)0000698356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Catalogue Number: 23900530
• Device Lot Number: 0000698356
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2023
• 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