MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CARDINAL HEALTH RAPID TEST HCG CASSETTE 30T; PREGNANCY TEST

Model Number	FHC-102
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) 2021: faint false positive result on cardinal health rapid test kit lot hcg1012010.Customer retested the same sample with an alternate lot of cardinal health rapid test kit and obtained a negative result.Customer alleges the negative result is the accurate result.No adverse outcomes occurred.Although further information was requested, no additional information was provided.
Additional Manufacturer Narrative
Pending results of investigation.
Additional Manufacturer Narrative
H3: device evaluated by manufacturer updated to 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.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, a sample hcg concentration below the cut-off level of this test might result in a weak line appearing in the test region (t) after an extended period of time.A line in the test region (t) seen after the read time could be indicative of a low hcg level in the sample.If such results are seen, it is recommended that the test be repeated with a new sample in 48-72 hours or that an alternate confirmation method is used.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: CARDINAL HEALTH RAPID TEST HCG CASSETTE 30T
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9975 summers ridge road; san diego, CA 92121 ; 8588052506
• MDR Report Key: 12900841
• Report Number: 2027969-2021-00114
• Device Sequence Number: 11749336
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: (01)20885380020251(17)221231(10)HCG1012010
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• 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): 01/05/2022

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: 12/31/2022
• Device Model Number: FHC-102
• Device Catalogue Number: B1077-22
• Device Lot Number: HCG1012010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/05/2022
• 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
• Patient Sex: Female