MAUDE Adverse Event Report: ABON BIOPHARM (HANGZHOU) CO., LTD. MEDLINE HCG PREGNANCY TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Lot Number HCG2052015

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2023

Event Type  Injury  

Event Description

While reviewing the product insert for pregnancy testing on (b)(6) 2023 to ensure compliance and check for any changes in the product, it was noted that the product in stock was "hcg pregnancy test cassette (urine)" lot: hcg2052015.We had 2 boxes in stock, both incorrect and with the same lot number.It was confirmed with materials management and the medline representative that the test that we ordered was the "hcg combo pregnancy test cassette (serum or urine)".The boxes for the two products look nearly identical.Medline's response to the error was "having the warehouse do an inventory check".My personal recommendation would be to have the box "banner" different colors for the different tests.If a pregnancy test at our facility was read as a negative but the patient was actually pregnant (the specificity is inferior in the test we received and the reagent may be wrong) it could result in permanent harm/ death to a fetus.

• Brand Name: MEDLINE HCG PREGNANCY TEST
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ABON BIOPHARM (HANGZHOU) CO., LTD.
• MDR Report Key: 16386405
• MDR Text Key: 309748248
• Report Number: MW5114979
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: HCG2052015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention