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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCUTREND TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIAGNOSTICS ACCUTREND TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Catalog Number 11447475160
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
Unique device identifier (udi) (b)(4).The customer¿s test strips and meter were requested for return.The customer confirmed no test strips are available for return.The investigation is ongoing.
 
Event Description
The initial reporter received questionable glucose results with an accutrend plus meter serial number (b)(4) compared to an unknown laboratory methodology.The reporter confirmed regular qc checks are not performed.The reporter's specific qc details were requested but not provided.The meter and laboratory measurements were performed within 15 minutes.The patient's meter glucose result was 44 mg/dl.The patient's laboratory glucose result was 88 mg/dl.
 
Manufacturer Narrative
The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.
 
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Brand Name
ACCUTREND TEST STRIPS
Type of Device
BLOOD GLUCOSE MONITORING TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key11805100
MDR Text Key249942365
Report Number1823260-2021-01405
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
PMA/PMN Number
K952875
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11447475160
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LEVOTHYROXINE; OVER THE COUNTER IRON SUPPLEMENT; LEVOTHYROXINE; OVER THE COUNTER IRON SUPPLEMENT
Patient Age29 YR
Patient Weight110
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