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

Model Number	FHC-A202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• MDR Report Key: 18758959
• Report Number: 3006984151-2024-00003
• Device Sequence Number: 15035005
• Product Code: JHI
• UDI-Device Identifier: 00613647000571
• UDI-Public: (01)00613647000571(17)250705(10)0000755094
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/22/2024
• Report Date (Section F): 02/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2025
• 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
• Distributor Facility Aware Date: 01/30/2024
• Device Age: 6 MO
• Date Report to Manufacturer: 01/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 02/19/2024