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

Catalog Number 11447475187

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's meters and strips were requested for investigation.The product has not been received at this time.Retention samples glucose lot 37996005 were measured with controls gkl 60 lot 346092-99 /gkl 180 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: 82 mg/dl, qc 2: 74 mg/dl, qc 3: 75 mg/dl.Investigation results using retention material: range gkl 180: 173 ¿ 232 mg/dl qc 1: 200 mg/dl, qc 2: 192 mg/dl, qc 3: 204 mg/dl.All results were within the control range.No significant differences to the laboratory method.Occupation is lay user/patient.The investigation is ongoing.

Event Description

The initial reporter received questionable glucose results using an accutrend plus meter when compared to an accu-chek instant meter.The meter result on the accutrend meter was 52 mg/dl.A few minutes later, the customer tested on the accu-chek instant meter.The result was 104 mg/dl.The accu-chek instant and accutrend meter's serial numbers were requested but not provided.It is not known which result was believed to be correct.The customer's normal glucose range is 100-110 mg/dl.

• 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: 10378007
• MDR Text Key: 202584580
• Report Number: 1823260-2020-01915
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 11447475187
• Device Lot Number: 37996005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/07/2020
• 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