MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CARDINAL HEALTH RAPID TEST HCG CASSETTE; PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation.

Event Description

Unspecified date: false negative result 1x on the cardinal health hcg urine cassette.The patient was not provided or withheld treatment nor were there changes in medication due to the hcg results reported.No adverse patient outcome reported.Customer was not the end-user, unable to provide any details- no additional information will be provided.Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique, storage conditions and patient specific factors per the package insert (pi).Technical services specialist informed customer per the pi: urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.False negative results may occur when the levels of hcg are below the sensitivity level of the test and very dilute urine specimens, as indicated by specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.Run controls on each new lot, each new shipment, monthly as a check on storage, each new untrained operator, and as otherwise required by your lab internal quality system procedures.

Manufacturer Narrative

Update to h6: method code 11 and 4101 added.Result code 213 added.Conclusion code 67 added.Investigation conclusion: an investigation was performed on retention and returned devices from the reported lot number.Retention and returned devices were tested with qc hcg-cutoff standard (25 miu/ml) and high hcg-positive clinical urine sample (206.17-229.23 iu/ml).Results were read at minutes 3 minutes and all devices produced expected positive results.No false negative results were observed.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lot met all final release 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.Limited information regarding patient and testing details could be obtained.A root cause could not be determined based on the information available.Per the product insert, very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.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: CARDINAL HEALTH RAPID TEST HCG CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 9341904
• MDR Text Key: 188827899
• Report Number: 2027969-2019-00590
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: FHC-102
• Device Lot Number: HCG9040046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1