MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URIN/SRM COMBO 5002 25; PREGNANCY TEST

Model Number	FHC-A202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending investigation.
Event or Problem Description
(b)(6) 2020: a (b)(6) old female patient visited the clinic for acne treatment.The patient's urine was collected at 14:50 and tested on the consult diagnostics hcg combo cassette at 15:09, which provided a positive result.The patients' blood was drawn for a confirmatory beta hcg.Confirmatory beta hcg provided a negative result of <2.39 miu/ml.No adverse patient outcomes reported.Limited information available.Although, further information was requested, no further information was able to be provided.Troubleshooting was performed with the customer with an emphasis on storage, handling and technique per the corresponding package insert-no deviations noted.
Additional Manufacturer Narrative
Investigation conclusion: retained and returned devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded the expected negative results.Retained and returned devices were also tested with low-concentration standards (4 miu/ml).The results were read at 4 minutes and 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 either retention or returned product.Complaints are tracked and trended on a monthly basis.Per the package insert, 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: CONSULT HCG URIN/SRM COMBO 5002 25
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca
• MDR Report Key: 10005728
• Report Number: 2027969-2020-00020
• Device Sequence Number: 2626229
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)210930(10)HCG9102014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 09/30/2021
• Device Model Number: FHC-A202
• Device Lot Number: HCG9102014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCUTANE (UNSPECIFIED DOSE)
• Patient Age: 23 YR
• Patient Weight: 81