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

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Waiting for customer response.Pending results of investigation.

Event Description

Unspecified date: false positive result when testing a urine specimen on the fisher sure-vue hcg stat serum/ urine test kit.The urine specimen provided a weak positive result.A serum sample on the same lot of fisher sure-vue hcg stat serum/ urine test kit provided a negative result.Confirmatory serum quant hcg provided a negative result of <3 miu/ml.No adverse outcomes reported.Although further information was requested, no additional information was provided.

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 and retain device testing could not be performed as a lot number was not provided.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.Case details indicate a positive hcg result was observed when testing urine and a negative hcg result was observed when testing serum; however the quantitive serum result was below sensitivity.A root cause could not be determined from the available information and as retain testing was unable to be performed.Complaints are tracked and trended on a monthly basis.Per the packet insert: this test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.A number of conditions other than pregnancy, including trophoblastic disease and certain nontrophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.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 TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9975 summers ridge road; san diego, CA 92121 ; 8588052506
• MDR Report Key: 12927328
• MDR Text Key: 283337381
• Report Number: 2027969-2021-00115
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female