MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG COMBO; HCG PREGNANCY TEST

Model Number FHC-202K

Device Problem False Negative Result (1225)

Patient Problem Spontaneous Abortion (4514)

Event Date 01/10/2023

Event Type  Injury  

Event Description

The customer reported a false negative result when testing with the henry schein hcg combo cassette (sensitivity of 25mlu/ml).A patient urine sample was tested as a screen prior to placement of an iud contraceptive.The urine sample was freshly voided, but was not a first morning sample.The result was read at the appropriate 3-minute read time, and was interpreted as negative, after which the iud was implanted.Approximately 15 minutes after the patient left the office, a medical assistant noticed that the result on the hcg combo cassette had changed from negative to positive, and the patient was called back for confirmatory testing.The quantitative blood test was positive with a result of 82mlu/ml, and the iud was subsequently removed.The patient experienced a miscarriage.The doctor continued to rack the patient's hcg level, which as 4mlu/ml as of 24-jan-2023.

• Brand Name: HENRY SCHEIN HCG COMBO
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• MDR Report Key: 16358873
• MDR Text Key: 309366432
• Report Number: 3006984151-2023-00001
• 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: Other
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: FHC-202K
• Device Catalogue Number: 9004075
• Device Lot Number: HCG2032009
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR
• Patient Sex: Female