MAUDE Adverse Event Report: GENZYME DIAGNOSTICS OSOM HCG COMBO TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Lot Number 211094

Device Problem Unable to Obtain Readings (1516)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

When the urine pregnancy test was filled with urine, no control line developed.The same thing has happened on multiple occasions from the same lot #.

• Brand Name: OSOM HCG COMBO TEST
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): GENZYME DIAGNOSTICS; 11 forbes road; northborough MA 01532
• MDR Report Key: 14458226
• MDR Text Key: 294397044
• Report Number: 14458226
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 211094
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female