MAUDE Adverse Event Report: ALERE SAN DIEGO ALERE HCG CASSETTE (25MIU/ML); HCG PREGNANCY TEST

Model Number 92217

Device Problem False Negative Result (1225)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

It was reported that a patient presented to the emergency room experiencing abdominal pain and a rapid hcg test was administered which produced a false negative result.The patient was then sent for a cat scan to determine the etiology of the abdominal pain.The result was suspected pregnancy.The patient was then confirmed 5 weeks pregnant with an ultrasound.Another hcg rapid test with the same urine sample was then performed with a positive result.An unknown pain medication was given to the patient for the abdominal pain and was discharged the same day.There was no additional information on the current status of the patient or fetus.Troubleshooting occurred by reviewing the event with the customer and technical information was provided regarding potential factors.It was acknowledged that the customer believes potential factors are related to the user not performing the test, or performing the test using the incorrect patient sample.Other potential causes were discussed related to technique, storage, handling, sample or a product issue, and limitations of the test.The package insert was reviewed for conformance and no deviations were noted from the information provided.

Manufacturer Narrative

Device evaluated by mfr: customer unwilling to return devices.Investigation conclusion: retained devices from the reported lot number were tested with qc cut-off standards (25 miu/ml) and high-hcg clinical urine samples (209.16-228.15 iu/ml).Results were read at 3 minutes and all devices yielded the expected positive results.No false negative 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-conformance's 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.The complainant suspected that the test that resulted in a false negative was either never actually performed, or was performed with the incorrect urine sample, however this cannot be confirmed.Per the package insert, 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: ALERE HCG CASSETTE (25MIU/ML)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9200096
• MDR Text Key: 170639362
• Report Number: 2027969-2019-00575
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10815845020109
• UDI-Public: (01)10815845020109(17)210331(10)HCG9030162
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 92217
• Device Lot Number: HCG9030162
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR