MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCUTREND ® TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	11447475160
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter stated controls "always pass when they are performed." the meter and test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.On a regular basis, accutrend strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.
Event or Problem Description
The initial reporter questioned cholesterol and glucose results on an accutrend plus meter with serial number (b)(4).The reporter could not provide any specific patient comparison results.A staff member tested on the meter and the glucose result was 29 mg/dl "which was obviously too low" as the staff member had no hypoglycemic symptoms and felt fine.
Additional Manufacturer Narrative
The device was slightly soiled with human material.The customer's meter was returned for investigation where it was tested using retention test strips, retention controls and ethylenediamine tetraacetic acid (edta) blood samples.The glucose test strip lot number used by the customer is not known.Retention test strips with lot number 481926-80 were used for the testing of the returned meter.The meter results were compared with the results from a reference device.Reference control ranges: control 1: 54 - 94 mg/dl.Control 2: 166 - 224 mg/dl.Testing results: reference device with control 1: results: 71mg/dl, 71 mg/dl and 76mg/dl mean of measurements: 72.7mg/dl.Customer's meter with control 1: results: 68mg/dl, 72 mg/dl and 70mg/dl mean of measurements: 70mg/dl.Reference device with control 2: results: 192 mg/dl, 197 mg/dl and 198 mg/dl.Mean of measurements: 195.7 mg/dl.Customer's meter with control 2: results: 186 mg/dl,186 mg/dl and 193 mg/dl.Mean of measurements: 188.3 mg/dl reference device with edta blood 1: results: 82 mg/dl, 82 mg/dl and 81 mg/dl.Mean of measurements: 81.7mg/dl.Customer's meter with edta blood 1: results: 75 mg/dl,79 mg/dl and 81 mg/dl.Mean of measurements: 78.3 mg/dl.Reference device with edta blood 2: results: 53 mg/dl, 59 mg/dl and 56 mg/dl.Mean of measurements: 56 mg/dl.Customer's meter with edta blood 2: results: 50 mg/dl, 60 mg/dl and 51 mg/dl.Mean of measurements: 53.7 mg/dl.Reference device with edta blood 3: results: 154 mg/dl, 150 mg/dl and 154 mg/dl.Mean of measurements 152.7 mg/dl.Customer's meter with edta blood 3: results: 153 mg/dl, 149 mg/dl and 150 mg/dl.Mean of measurements 150.7 mg/dl.All results were within the control range.There were no significant differences from the customer's meter compared with the reference device.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ACCUTREND ® TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12916812
• Report Number: 1823260-2021-03561
• Device Sequence Number: 17460633
• Product Code: CGA
• UDI-Device Identifier: 00365702456105
• UDI-Public: 00365702456105
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K952875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 11447475160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female