MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MEDLINE HCG URINE CASSETTE; HCG PREGNANCY TEST

Catalog Number FHC-102

Device Problem False Negative Result (1225)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting was performed with the customer.The hcg product information notice was reviewed which discusses the intended use and limitations of the test.Test provides only 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.Investigation conclusion will be provided once the investigation is complete.

Event Description

The customer reported receiving a false negative hcg result on the medline hcg urine cassette as compared to a positive hcg result obtained on an unspecified confirmatory test method.(b)(6) 2018: positive result obtained on first response home pregnancy test kit.Unable to specify whether sample was a first morning urine.(b)(6) 2018: positive result obtained on first response home pregnancy test kit.Unable to specify whether sample was a first morning urine.Patient present to the facility to confirm results of the home pregnancy test kits.A negative hcg result was obtained on the medline hcg urine cassette test kit at 3:30 pm.(b)(6) 2018: patient blood work was performed and a positive hcg result was obtained (no concentration listed on the lab report).No further information provided regarding confirmatory test method.No treatment was provided/withheld based on the false negative hcg result obtained on the medline hcg urine cassette.

Manufacturer Narrative

Troubleshooting was performed with the customer.The hcg product information notice was reviewed which discusses the intended use and limitations of the test.Test provides only 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.Investigation conclusion: an investigation was performed on retention product from the reported lot number.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 lot met quality control specifications.A root cause could not be determined from the available information as the retention product performed as expected.Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still expected, a first morning urine specimen should be collected 48 hours later and tested.

• Brand Name: MEDLINE HCG URINE CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 8127221
• MDR Text Key: 129595754
• Report Number: 2027969-2018-00159
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30888277191871
• UDI-Public: (01)30888277191871(17)200430(10)HCG8050030
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: FHC-102
• Device Lot Number: HCG8050030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVOTHYROX NUNUPRICIN CREAM
• Patient Age: 28 YR