MAUDE Adverse Event Report: ALERE CARDINAL HEALTH BRAND HCG COMBO RAPID TEST; HCG COMBO RAPID KIT

Lot Number HCG7040039

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Cardinal brand hcg combo kit states a minimum detection limit of 10mlu/ml, but comes up positive at 5mlu/ml."is the product compounded: no, is the product over-the-counter: no.".

• Brand Name: CARDINAL HEALTH BRAND HCG COMBO RAPID TEST
• Type of Device: HCG COMBO RAPID KIT
• Manufacturer (Section D): ALERE; cn
• MDR Report Key: 6848291
• MDR Text Key: 85573884
• Report Number: MW5072002
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: HCG7040039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1