MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH ALERE NMP22 BLADDER CHEK 24T; BLADDERCHECK TEST & CONTROL KIT

Catalog Number	D1200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
The hospital reported that there were affected kit boxes that had damaged desiccant pouches.The desiccant scattered when unpacking the reagent board and the packaging bag splashed into the eyes of the operator.They went to the ophthalmology department for medical treatment without major problems.No other serious injuries.
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.
Additional Manufacturer Narrative
The manufacturing records and quality control release testing was reviewed for kit part number d1200 / lot 158575 and device part number f4090 / lot 154909.Quality control release testing met specifications and there were no broken or unsealed desiccants observed.The current overall incident rate for broken/damaged/defective components for this specific lot based on the total distributed devices is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However the product will continue to be monitored and tracked.
Additional Manufacturer Narrative
Correction: h10 the manufacturing records and quality control release testing was reviewed for kit part number d1200 / lot 158703 and device part number f4090 / lot 154900.Quality control release testing met specifications and there were no broken or unsealed desiccants observed.The current overall incident rate for broken/damaged/defective components for this specific lot based on the total distributed devices is 16.2%.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However the product will continue to be monitored and tracked.

• Brand Name: ALERE NMP22 BLADDER CHEK 24T
• Common Device Name: BLADDERCHECK TEST & CONTROL KIT
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCABOROUGH; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: kindra sudduth ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 12783652
• Report Number: 1221359-2021-03461
• Device Sequence Number: 11813477
• Product Code: NAH
• UDI-Device Identifier: 10811877010569
• UDI-Public: 011081187701056910158703
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P940035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D1200
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 05/12/2022; 06/27/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 06/01/2022; 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male