MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERUM)(40T/K)

Model Number	FHC-202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the expected negative results.Retained devices were also tested with hcg-negative clinical serum samples.The results were read at 5 minutes and again all devices yielded the expected 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.Please note, it is important to use a timer and read the results at the correct read time to ensure accurate results.Per the package insert, read the result at 3 minutes when testing a urine specimen, or at 5 minutes when testing a serum specimen.Do not interpret results after the appropriate read time.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 or Problem Description
Unspecified date: false positive result obtained on the hcg one step pregnancy test device.Line was a weak positive, so the sample was sent to the lab for a confirmatory hcg quant.Confirmatory quant provided a negative result; exact result not provided.Although requested, no further information was able to be obtained.Customer unresponsive.

• Brand Name: HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERUM)(40T/K)
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 12180436
• Report Number: 2027969-2021-00067
• Device Sequence Number: 1622004
• Product Code: JHI
• UDI-Device Identifier: 10815845020116
• UDI-Public: (01)10815845020116(17)220930(10)HCG0102037
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: FHC-202
• Device Lot Number: HCG0102037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1