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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK PERFORMA TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIABETES CARE, INC. ACCU-CHEK PERFORMA TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Lot Number 478455
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Fainting (1847); Vomiting (2144); Coma (2417)
Event Date 10/05/2020
Event Type  Injury  
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 patient received a reading of 44 mg/dl on (b)(6) 2020 at 22:00.The customer stated that she suffered from abdominal pain, breathing difficulties and vomiting and fell into a coma.She was taken to the hospital, where the hospital staff measured her blood glucose level with the hospital's meter (brand unknown).The value was "hi".The time between the measurement of 44 mg/dl and the measurement in the hospital "hi" was 30 minutes.The treatment received at the hospital was not specified.
 
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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 Key10649960
MDR Text Key210439557
Report Number3011393376-2020-03666
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/31/2021
Device Lot Number478455
Was Device Available for Evaluation? No
Date Manufacturer Received12/26/2020
Patient Sequence Number1
Treatment
ACTRAPID INSULIN; LANTUS INSULIN; ACTRAPID INSULIN; LANTUS INSULIN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age9 YR
Patient Weight39
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