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

Catalog Number 11447475187

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's meters and strips were requested for investigation.The products have not been received at this time.Retention samples for glucose lot 349029-04 were measured with retention controls gkl60 lot 346092-99 /gkl180 lot 346093-99 and 3 edta blood on reference devices compared to laboratory method.Ranges control solutions: range gkl 60: 58 ¿ 98 mg/dl.Investigation results using retention material: qc 1: 78 mg/dl, qc 2: 74 mg/dl, qc 3: 72 mg/dl.Investigation results using retention material: range gkl 180: 166 ¿ 224 mg/dl, qc 1: 195 mg/dl, qc 2: 194 mg/dl, qc 3: 187 mg/dl.All results were within the control range.No significant differences to the laboratory method.The investigation is ongoing.

Event Description

The initial reporter received questionable glucose results using an accutrend plus meter when compared to an accu-chek active meter.The meter result on the accutrend meter was 82 mg/dl.A few minutes later, the customer tested on the accu-chek active meter.The result was 110 mg/dl.The customer provided two accutrend meter serial numbers (b)(4).It is unknown which meter gave the result.The accu-chek active meter's serial number was requested but not provided.It is not known which result was believed to be correct.

• Brand Name: ACCUTREND PLUS GLUCOSE STRIPS
• Type of Device: 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: 10373563
• MDR Text Key: 202051531
• Report Number: 1823260-2020-01905
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K051376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 11447475187
• Device Lot Number: 34902904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1