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

Model Number	07453701001
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	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 86 mg/dl, 160 mg/dl, 164 mg/dl, a result in the "90's mg/dl", and 116 mg/dl.
Additional Manufacturer Narrative
Device received in a condition which made analysis impossible.Customer returned an empty test strip vial.

• Brand Name: ACCU-CHEK ® GUIDE TEST STRIPS
• 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: 9660224
• Report Number: 3011393376-2020-00449
• Device Sequence Number: 18920881
• Product Code: NBW
• UDI-Device Identifier: 00365702701977
• UDI-Public: 00365702701977
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K160944
• 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): 03/18/2020

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 Expiration Date: 03/17/2021
• Device Model Number: 07453701001
• Device Catalogue Number: 07453701001
• Device Lot Number: 101443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/18/2020
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 100