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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Code Available (3191)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

It was reported that on (b)(6) 2019, the patient presented to the facility for an unknown reason.The patient's urine was tested on the fisher sure-vue hcg urine cassette and produced a negative result.The patient was sent for a ct scan.The customer then noticed a faint line on the test cartridge after the ct scan was performed.It is unknown how much time had passed since the patient had been tested.The customer repeated the test and another negative result was obtained.A serum sample was then collected and sent for confirmatory testing on the same day and produced a beta quant=265 miu/ml.No further information was available.Troubleshooting was conducted with the customer.Technical services discussed with the customer possible causes for unexpected results, focusing on proper sampling technique and storage conditions per the package insert.

Manufacturer Narrative

The lot number of the affected product could not be provided.Therefore, all retained final-product lots within the expiration date of the date of occurrence were evaluated.Devices from these lots were tested with quality control cut-off (25miu/ml) and middle positive standard (100miu/ml).All devices were read at 3 minutes and yielded expected positive results.Manufacturing batch records of the final-product, relevant product components, and quality control release data for each of these lots were reviewed.No relevant non-conformance's, deviations, or abnormalities were found.All quality control specifications were met.All retention products performed as expected during in-house testing and could not replicate the reported complaint.Complaints are tracked and trended on a monthly basis.Case details did not indicate if the urine sample was a first morning catch.Per the package insert, very dilute urine may not contain representative levels of hcg.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 URINE CASS. (30T)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8712125
• MDR Text Key: 151005343
• Report Number: 2027969-2019-00116
• Device Sequence Number: 1
• Product Code: JHI
• 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: 07/22/2019

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 Model Number: FHC-102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 07/21/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1