MAUDE Adverse Event Report: ABON BIOPHARM (HANGZHOU) CO., LTD. CLEARVIEW HCG DEV(URINE)20T; CLEARVIEWTM HCG CASSETTE (25 MIU/ML)

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  

Event Description

(b)(6) 2023 the customer called ts to report a false positive result on a patient obtained with clearview hcg dev(urine) 20t ref.Cv506788c, lot 0000743558.The customer provided the below information : the patient came to the hospital for a planned surgery.The patient was quite old and had past the conceiving age.As the rapid test result was positive, the surgery was cancelled.A blood test was also done and confirmed later that the woman was not pregnant.

Manufacturer Narrative

Investigation summary.1.The alleged false positive occurred on fhc-102 product.Customer reported false positive result on a patient.The patient was quite old and had past the conceiving age.A blood test was also done and confirmed later that the woman was not pregnant.Information regarding product storage and testing technique is not provided.It is unable to identify if any misuse or deviation against the package insert.2.The batch record of 0000743558 was reviewed, the quality control release data met release specification, no deviation was observed in the finished product, semi-finished strip as well the strip components manufacturing process, the materials used in the key components met manufacturing criteria.3.The retain product investigation was performed on lot 0000743558.Performed visual inspection for the packaging and devices, 29 retained devices were intact.29 retained devices were tested with clinical negative urine samples, results were read at 3 minutes.All retained devices showed expected negative results.False positive issue were not observed.4.Unable to determine assignable cause.The complaint investigation provided insufficient objective evidence to determine the most probable identifiable factor to assign any other available cause code.According to product insert, this test may produce false positive results.A number of conditions other than pregnancy can cause elevated levels of urinary hcg e.G.Menopause, trophoblastic disease and certain non-trophoblastic neoplasms.False positive and false negative pregnancy tests may also be observed in patients with abnormal bladder or kidney function e.G.Enterocystoplasties and renal failure.Drugs containing hcg may also interfere with clearview hcg dev(urine)20t, and produce misleading results.5.The device was involved in the reported event as described by the complainant.The device was used for diagnostic purposes and the user reported the device generated a false positive.No death or serious injury occurred, the event is related to product result, the reported issue was not replicated during investigation, and therefore no product deficiency was identified by the investigation.The complaint is tracked and trended on a monthly basis.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.8 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.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.H3 other text : device return is not anticipated.

• Brand Name: CLEARVIEW HCG DEV(URINE)20T
• Type of Device: CLEARVIEWTM HCG CASSETTE (25 MIU/ML)
• Manufacturer (Section D): ABON BIOPHARM (HANGZHOU) CO., LTD.; #198 12th street east; economic and technological; hangzhou 31001 8; CN 310018
• Manufacturer Contact: grant bin zhang ; #198 12th street east; economic and technological; hangzhou 31001-8 ; CN 310018
• MDR Report Key: 18920504
• MDR Text Key: 337855216
• Report Number: 3005641941-2024-00001
• 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: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2024
• 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