MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. SURE-VUE SERUM/URINE HCG-STAT; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-A202

Device Problem False Negative Result (1225)

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

Event Date 01/10/2024

Event Type  Injury  

Event Description

The customer reported a false negative result when testing a patient urine sample using the sure-vue serum/urine hcg-stat.The patient had been experiencing abdominal pain for over a year, and following the negative hcg result the patient underwent a laparoscopic cholecystectomy with general anesthesia.The patient took an at-home pregnancy test 19 days after the cholecystectomy with a positive result, which was confirmed at the clinic facility.The patient was determined to have been three and a half weeks pregnant at the time of the negative result, however quantitative testing was not performed at the time.While it is unknown whether the hcg concentration of the sample was actually above the level of detection of the sure-vue serum/urine hcg-stat, this is conservatively being considered a false negative.The pregnancy was considered viable as of (b)(6) 2024; no adverse outcomes were reported.However, due to the potential for harm to the fetus due to exposure to anesthesia, this will be considered an other serious/important medical event.

• Brand Name: SURE-VUE SERUM/URINE HCG-STAT
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• MDR Report Key: 18758959
• MDR Text Key: 336005413
• Report Number: 3006984151-2024-00003
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/19/2024,02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Catalogue Number: 23900530
• Device Lot Number: 0000755094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2024
• Distributor Facility Aware Date: 01/30/2024
• Device Age: 6 MO
• Date Report to Manufacturer: 01/30/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female