MAUDE Adverse Event Report: ALERE SAN DIEGO FISHER-SURE-VUE HCG STAT SERUM/URINE; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

Results pending the completion of the investigation.

Event Description

On (b)(6) 2020, a patient with a common bowel duct stone arrived at the er needing radiology testing.Due to standard procedure, a serum sample was taken, centrifuged and applied to a fisher-sure-vue hcg stat serum/urine test with a positive result.On an unknown date, the same sample was used for confirmatory testing with a siemens vista analyzer.The result was positive, <8 miu/ml, 1-3 is reference range for nonpregnant females.A second sample was run with negative results (data not known).There was no adverse event, no treatment, procedure, or medications delayed or provided based on the alleged false positive result.

Manufacturer Narrative

Investigation conclusion: 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.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.Quantitative hcg analysis of the patient serum sample provided found that the hcg concentration was 10.7 miu/ml.The sure-vue serum/urine hcg-stat has a sensitivity of 10 miu/ml in serum, therefore the positive result reported by the customer when testing this sample is accurate.The product performed as expected.

• Brand Name: FISHER-SURE-VUE HCG STAT SERUM/URINE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 10980469
• MDR Text Key: 248143191
• Report Number: 2027969-2020-00083
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00613647000533
• UDI-Public: (01)00613647000533(17)220331(10)HCG0042024
• 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: 03/03/2021

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: 03/31/2022
• Device Model Number: FHC-A202
• Device Catalogue Number: 23900531
• Device Lot Number: HCG0042024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR