MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG ONE STEP PREGNANCY TEST DEVICE (URINE)

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem Ectopic Pregnancy (1819)

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

False (b)(6) hcg result on the hcg one step pregnancy test device kit.Patient returned days later with a ruptured ectopic pregnancy.Although further information was requested, no further information was provided.

Manufacturer Narrative

As a lot number was not provided, an investigation was performed on retention product from lots that were within expiration date and were distributed to the uk.Retention devices were tested with qc cutoff standards (25 miu/ml).Results were read at 3 minutes, and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and found that the lots met quality control specifications.Review of the last two years of complaint history found that the rate of false negative complaints is steady, and no indications of a systemic issue were found.Furthermore, review of the investigations performed on hcg product found that no false negative complaints have been replicated on retention product over that period.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.

Manufacturer Narrative

Investigation conclusion: further investigation to determine whether the product failed to meet specifications cannot be pursued because the customer did not provide a lot number.The root cause cannot be determined due to insufficient information.No corrective action is required.Review of the last two years of complaint history found that the rate of false negative complaints is steady, and no indications of a systemic issue were found.Furthermore, review of the investigations performed on hcg product found that no false negative complaints have been replicated on retention product over that period.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.

• Brand Name: HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summerse ridge rd; san diego CA 92121
• MDR Report Key: 8269265
• MDR Text Key: 133831315
• Report Number: 2027969-2019-00008
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention