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

Catalog Number 07819382037

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported the patient received the following results within 15 minutes: 33 mg/dl, lo (= less than 10 mg/dl) and 45 mg/dl.

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.

Manufacturer Narrative

Correction: in section b5, it was reported the patient received the following results within 15 minutes: 33 mg/dl (system 1), "lo" mg/dl (less than 10 mg/dl; system 1), 45 mg/dl (system 1) and 188 mg/dl (system 2).This case, with patient identifier cn-483012 (system 1), is related to case with patient identifier cn-483012b (system 2).

Event Description

It was reported the patient received the following results within 15 minutes: 33 mg/dl (system 1), "lo" mg/dl (less than 10 mg/dl; system 1), 45 mg/dl (system 1) and 188 mg/dl (system 2).

• Brand Name: ACCU-CHEK ® INSTANT TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18702518
• MDR Text Key: 335354203
• Report Number: 3011393376-2024-00392
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 07819382037
• Device Lot Number: 302673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/07/2024; 04/09/2024
• Supplement Dates FDA Received: 02/15/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• Is the Device Single Use?: No
• Patient Sequence Number: 1