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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® PERFORMA COMBO; BLOOD GLUCOSE MONITORING DEVICE
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® PERFORMA COMBO; BLOOD GLUCOSE MONITORING DEVICE Back to Search Results
Catalog Number 05947138005
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
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 that the blood glucose meter inadvertently transmitted insulin amounts to the infusion device.Within five minutes, the blood glucose meter transmitted insulin amounts of 0.3 insulin units, 0.4 insulin units, 3.3 insulin units and 0.4 insulin units.The user had a low blood glucose level of 56 mg/dl during the event.
 
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Brand Name
ACCU-CHEK ® PERFORMA COMBO
Type of Device
BLOOD GLUCOSE MONITORING DEVICE
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
SANMINA-SCI CORPORATION
rathealy road
na
fermoy 00000
EI   00000
Manufacturer Contact
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key12438493
MDR Text Key270287316
Report Number3011393376-2021-02766
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number05947138005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Patient Sequence Number1
Treatment
UNKNOWN INSULIN.; UNKNOWN INSULIN
Patient SexMale
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