MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCUTREND CHOLESTEROL; CHOLESTEROL (TOTAL) TEST SYSTEM

Catalog Number	05213312160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quality controls were performed on all of the involved meters and were acceptable.The customer stated the strips and meters are left in a car at times during health fairs and the strips are exposed to extreme temperatures at times.The meter and strips have been requested for return.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable cholesterol results from multiple accutrend plus meters.The customer used meter serial numbers (b)(4).The customer noticed they were getting more hi (>300 mg/dl) results with their accutrend meters than normal.The customer performed a comparison against cardiochek meters that provides a breakdown of the different cholesterol results and they got a hi on that brand.When they broke the result down, the total cholesterol result was 198 mg/dl.
Additional Manufacturer Narrative
One vial of cholesterol test strips lot 566007-01 with 13 test strips inside and one vial of cholesterol lot 539009-21 also 13 test strips were received for investigation.No customer devices were available to be returned.Retention samples of lot 566007-01 and lot 539009-21 and the customer's returned strips were measured with low and high control solutions and 3 edta blood on reference meters.All results are within the range.No abnormalities were noticed with the returned strips.

• Brand Name: ACCUTREND CHOLESTEROL
• Common Device Name: CHOLESTEROL (TOTAL) TEST SYSTEM
• 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: 14842770
• Report Number: 1823260-2022-01888
• Device Sequence Number: 4744474
• Product Code: CHH
• UDI-Device Identifier: 00365702276109
• UDI-Public: 00365702276109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 09/06/2022

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 05213312160
• Device Lot Number: 56600701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/06/2022
• 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: Unknown