MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG URINE CASSETTE 100T; PREGNANCY TEST

Model Number	FHC-102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending investigation.
Event or Problem Description
Unspecified dates: customer states they have experienced false negative results on 6-7 female patients, ages ranging from (b)(6), when using the same lot of the henry schein hcg urine cassette kit.Patient tests were performed on different days, but customer was unable to provide patient specific information.Urine specimens used were not first morning urine samples.Confirmatory blood work (hcg quantum test) was performed for each patient and provided positive results for all patients.Exact results were not provided.No adverse patient outcomes reported.Although requested, no further information was provided.Customer was unresponsive.
Additional Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with qc cut-off standards and high-hcg clinical urine samples.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.Case details indicate that the tests were read immediately after adding the sample.Per the instructions for use, read the result at 3-4 minutes.Incorrect read time cannot be ruled out as the cause of the reported issue.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.A first morning urine specimen is preferred since it generally contains the highest concentration of hcg; however, urine specimens collected at any time of the day may be used.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE 100T
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 11925868
• Report Number: 2027969-2021-00052
• Device Sequence Number: 3179003
• Product Code: JHI
• UDI-Device Identifier: 10304040024116
• UDI-Public: (01)10304040024116(17)220930(10)HCG0102013
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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-102
• Device Catalogue Number: 9004074
• Device Lot Number: HCG0102013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1