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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK PERFORMA TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIAGNOSTICS ACCU-CHEK PERFORMA TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Catalog Number 07299702001
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Manufacturer Narrative
Occupation is a lay user/patient.The meter and test strips were requested for investigation.The product has not been received at this time.A routine retention testing process has been implemented for all strip lots currently valid in the market.All retention data is reviewed on a monthly basis and appropriate actions are taken as needed.
 
Event Description
There was a complaint of discrepant glucose results for one patient tested with accu-chek performa meter with an unknown serial number.The result from the meter was 200 mg/dl.The result from the meter was 110 mg/dl.The timing between tests was within ten minutes.
 
Manufacturer Narrative
Field h3 updated.Since no product was returned, the cause of the event could not be determined.
 
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Brand Name
ACCU-CHEK PERFORMA TEST STRIPS
Type of Device
BLOOD GLUCOSE MONITORING TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key12474422
MDR Text Key271513030
Report Number1823260-2021-02692
Device Sequence Number1
Product Code LFR
UDI-Device Identifier00365702602106
UDI-Public00365702602106
Combination Product (y/n)N
PMA/PMN Number
K043474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number07299702001
Device Lot Number479457
Was Device Available for Evaluation? No
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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