MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG CASSETTE RAPID TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Hormonal Imbalance (4495)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with qc cut-off positive controls (25 miu/ml) and high-hcg clinical urine samples (202.7¿222.9 iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false negative 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: ¿ very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.¿ false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.H3 other text : the customer did not elect to return devices for investigation.
Event or Problem Description
The distributor reported an unspecified number of false negative results when testing patient samples using the hcg cassette rapid test, but was only able to provide information for one patient.The patient was tested as a screen prior to receiving a depo-provera injection for contraception.The patient tested negative on the hcg cassette rapid test and received the depo-provera injection.An unspecified urine pregnancy test was performed at another clinic 26 days later with a positive result.A quantitative blood hcg test was performed the following day with a result of 41,863 (units not specified), and the patient was diagnosed as pregnant.The patient's progesterone was determined to be low (5.8, units not specified); the patient was prescribed 200 mg progesterone per day.

• Brand Name: HCG CASSETTE RAPID TEST
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 16857706
• Report Number: 2027969-2023-00032
• Device Sequence Number: 8555905
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: (01)20885380020251(17)240531(10)HCG2062030
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: FHC-102
• Device Catalogue Number: B1077-22
• Device Lot Number: HCG2062030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Race: Black Or African American