MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG DIPSTICK 25T (URINE); PREGNANCY TEST

Model Number FHC-101

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021: false positive result on the henry schein hcg dipstick kit.No adverse outcomes reported.Although requested, no further information was provided.Customer unresponsive.

Manufacturer Narrative

Customer / distributor unwilling to return / unresponsive.Pending results of investigation.

Manufacturer Narrative

Investigation conclusion: retained 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 number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.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: HENRY SCHEIN HCG DIPSTICK 25T (URINE)
• Type of Device: 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: 12817151
• MDR Text Key: 285342999
• Report Number: 2027969-2021-00109
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024093
• UDI-Public: (01)10304040024093(17)230228(10)HCG1022068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: FHC-101
• Device Catalogue Number: 9004072
• Device Lot Number: HCG1022068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female