MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® COMPACT TEST DRUM; BLOOD GLUCOSE MONITORING TEST STRIPS

Model Number	05599415160
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 40 mg/dl and 240 mg/dl.

• Brand Name: ACCU-CHEK ® COMPACT TEST DRUM
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9741004
• Report Number: 3011393376-2020-00686
• Device Sequence Number: 16637720
• Product Code: NBW
• UDI-Device Identifier: 00075537474198
• UDI-Public: 00075537474198
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

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: Lay User/Patient
• Device Model Number: 05599415160
• Device Catalogue Number: 05599415160
• Device Lot Number: 05599415160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 05/06/2020
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 73