MAUDE Adverse Event Report: ALERE SAN DIEGO CONSULT HCG URINE/SERUM COMBO TEST; HCG PREGNANCY TEST

Model Number	FHC-A202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has product, awaiting response.Results pending completion of the investigation.
Event or Problem Description
(b)(6) 2021: a patient with breast tenderness was administered the consult hcg urine/serum combo test and had 2 false positive results with a urine sample.It was not compatible with the clinical picture of the patient, therefore a blood sample was drawn and the hcg lab result was negative (<1miu/ml) using a siemens dimension vista instrument.The quality controls were run on 09/07/2021 and performed as expected.There was no adverse event.
Additional Manufacturer Narrative
D9: device returned to the manufacturer 01/26/2022.H3: yes.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-hcg negative urine samples.The results were read at 4 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 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 URINE/SERUM COMBO TEST
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9975 summers ridge road; san diego, CA 92121 ; 8588052506
• MDR Report Key: 12554865
• Report Number: 2027969-2021-00085
• Device Sequence Number: 16422231
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)230131(10)HCG1022005
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 01/31/2023
• Device Model Number: FHC-A202
• Device Lot Number: HCG1022005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIRTH CONTROL PILLS; IRON SUPPLEMENT; BIRTH CONTROL PILLS; IRON SUPPLEMENT
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White