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

Catalog Number 06454011136

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported the patient received the following results within 15 minutes: 72 mg/dl (active system) and 137 mg/dl (performa system).

• Brand Name: ACCU-CHEK PERFORMA TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10296137
• MDR Text Key: 199500899
• Report Number: 3011393376-2020-02564
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 06454011136
• Device Lot Number: 478377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 11/05/2020
• Patient Sequence Number: 1
• Treatment: JANUMET TABLETS; VITAMINS; JANUMET TABLETS; VITAMINS
• Patient Age: 67 YR
• Patient Weight: 42