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

Model Number FHC-101

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

The distributor reported the event on behalf of the customer.The customer alleged receiving a (b)(6) result using a (b)(6) dipstick test.Per the customer, a digital clock was used for the test instead of a timer.No information on confirmatory testing was provided.Although requested, no additional information was provided.

Manufacturer Narrative

Investigation conclusion: retention and returned products were tested with hcg quality control cut-off standard (25miu/ml) and high level hcg clinical urine (212.6iu/ml, 215.2iu/ml, 203.5iu/ml).All devices showed positive results at read time and met quality control specifications.No false negative results were obtained during in-house testing.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformance, deviations, or abnormalities were found.All quality control specifications were met.Retention and returned products performed as expected during in-house testing and could not replicate the reported complaint.This issue will be subject to tracking and trending.Case details do not indicate if the urine sample was a first morning catch.Per the package insert, very dilute urine may not contain representative levels of hcg.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.Based on the information available, there is no indication of a product deficiency and no corrective action is required.(additional device information) updated to include unique device identifier (b)(4).

• Brand Name: HENRY SCHEIN HCG DIPSTICK 25T (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7803578
• MDR Text Key: 117859653
• Report Number: 2027969-2018-00105
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101
• Device Lot Number: HCG7120122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1