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	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable glucose results from accutrend plus meter serial number (b)(4).At 8:20am the result was 108 mg/dl.At 8:25 am the result was 124 mg/dl.At 8:34 am the result was 141 mg/dl.The same fingerstick was used to obtain all three tests.None of the results were believed to be correct.
Additional Manufacturer Narrative
The 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.
Additional Manufacturer Narrative
No material was returned by the customer.Retention samples of glucose lot 48192609 were measured with retention controls and 3 edta blood on reference devices which were compared to a laboratory method.All results were within the control range.No significant differences from reference devices to lab method.

• 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: 13591356
• Report Number: 1823260-2022-00494
• Device Sequence Number: 17597228
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 48192609
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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 Age: 16 YR
• Patient Sex: Male
• Patient Weight: 63 KG