MAUDE Adverse Event Report: ALERE SAN DIEGO FISHER-SURE-VUE HCG-STAT SRM/URINE (30T); PREGNANCY HCG TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

The customer reported a false positive serum result when the fisher-sure-vue hcg-stat serum/urine was administered during preadmission testing on a (b)(6) year old female patient who had entered the er with ketoacidosis.The blood sample was spun prior to this test.A urine sample was then used with a competitor's test with a negative result.Then a serum sample was used again on the same lot of the fisher-sure-vue hcg-stat serum/urine test with a negative result.Controls were run on (b)(6) 2020 successfully.No treatment was withheld, given or delayed due to the false positive result.There was no report of an adverse event.

Manufacturer Narrative

D4: udi (b)(4).Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical serum samples.The results were read at 5 and 6 minutes and all devices yielded the expected negative results.No false positive 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-conformances 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.No deviations in technique, storage, or handling were noted in the information provided.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.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: FISHER-SURE-VUE HCG-STAT SRM/URINE (30T)
• Type of Device: PREGNANCY HCG TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego, ca
• MDR Report Key: 10347876
• MDR Text Key: 201218249
• Report Number: 2027969-2020-00037
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: FHC-A202
• Device Lot Number: HCG9112068
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR