MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. FISHER-SURE-VUE HCG STAT SRM/URINE (50T); PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem Distress (2329)

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation.

Event Description

Unspecified date: patient presented to facility for a planned surgery (type of surgery unspecified).Customer states it was not an emergent situation.A patient urine specimen was tested on the fisher sure-vue hcg stat serum/urine kit and a positive result was obtained.A patient serum specimen was tested on the fisher sure-vue hcg stat serum/urine kit and a negative result was obtained.A confirmatory beta quant hcg test was performed on the beckman coulter dxi analyzer and a negative result of <0.6 miu/ml was obtained.The patients surgery was initially delayed, however, it was performed 3 hours later.Customer states the patient experienced emotional distress, however, no adverse outcomes occurred.No remedial actions were needed.

Manufacturer Narrative

D9: device available for evaluation changed to "no" h3: although requested, devices were not returned.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples and sub-cutoff urine standards (4 miu/ml).The results were read at 3 and 4 minutes and all devices yielded the expected negative results.No false positive results were observed during in-house testing.Although the tracking number shows that the returned devices were delivered in san diego, a search of the facility did not locate the product.Therefore, testing of returned devices could not be included in the investigation.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.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 (50T)
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 12268242
• MDR Text Key: 264778856
• Report Number: 2027969-2021-00074
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)221231(10)HCG0122141
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: FHC-A202
• Device Catalogue Number: B1077-23
• Device Lot Number: HCG0122141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORTHOTRICYCLEN; ORTHOTRICYCLEN
• Patient Age: 42 YR
• Patient Weight: 96