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

Catalog Number 11447475160

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained that the accutrend plus meter with serial number (b)(4) was not detecting the test strip.The customer was instructed to clean the meter and repeat testing.The customer was contacted 5 days later and the customer stated that the glucose results were lower than normal.The customer stated that his results are usually high for glucose, triglycerides, and cholesterol.The customer stated that he had a check-up at the hospital and took his accutrend plus equipment with him to verify its functionality.On a different meter at the hospital, the result was 200 mg/dl and 216 mg/dl.The meter that was used at the hospital was not known.Within the same timeframe, the customer received a glucose result of lo (result less than 20 mg/dl) on his accutrend plus meter.The exact time between the result at the hospital and the customer¿s result was not known.There was no allegation of an adverse event.

Manufacturer Narrative

The test strip lot and the expiration date were provided.

Manufacturer Narrative

The customer returned the meter for investigation.None of the customer's test strips were available.The customer's returned meter and a reference meter were tested with the retention strip lot 18615200 in comparison to a reference strip lot.For this purpose, two human blood samples and qc were used.All measurements were within range.There were no differences between the customer's meter and reference meter.The investigation was unable to find a definitive root cause.

• Brand Name: ACCUTREND ® TEST 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: 7274204
• MDR Text Key: 100454975
• Report Number: 1823260-2018-00464
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K952875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 11447475160
• Device Lot Number: 18615206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2018
• 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