MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II BASE UNIT LIGHT; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number	08376824190
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was requested for investigation and has not been received at this time.If the product is returned in the future, a follow-up report will be submitted. .
Event or Problem Description
We received an allegation of a blackened left charging contact of the accu-chek inform ii meter charging base.The reporter also stated that the base no longer charges.There was no melted plastic observed on the base.The reporter confirmed none of the meters were burnt and that there was no fire or serious injury that occurred.
Additional Manufacturer Narrative
The accu-chek inform ii base unit was received for investigation.A visual examination revealed corrosion on the contact which caused the base unit to charge the meters insufficiently.The investigation determined that the issue was consistent with customer mishandling.The investigation did not identify a product problem.Medwatch fields d9 and h3 have been updated.

• Brand Name: ACCU-CHEK INFORM II BASE UNIT LIGHT
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15872451
• Report Number: 1823260-2022-03774
• Device Sequence Number: 12134210
• Product Code: NBW
• UDI-Device Identifier: 07613336155318
• UDI-Public: 07613336155318
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 08376824190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown