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

Catalog Number 11447475160

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant low glucose results for 3 patients tested on accutrend plus meter serial number (b)(4).Patient 1 initial result at 12:13 p.M.Was lo (result less than 20 mg/dl).The patient was re-tested at 12:14 p.M.With a result of 86 mg/dl.The patient was tested a 3rd time at 12:16 p.M.With a result of 209 mg/dl.The customer did not think any of the results were correct.The patient was tested at the hospital laboratory within approximately 30 minutes with a result of 166 mg/dl.On (b)(6) 2019 patient 2 initial result was 49 mg/dl at 3:28 p.M.The patient was re-tested at 3:31 p.M.And 3:32 p.M.With results of 170 mg/dl and 173 mg/dl.The customer thought the result of 170 mg/dl was correct.On (b)(6) 2019 patient 3 initial result was lo (result less than 20 mg/dl) at 11:32 a.M.The patient was re-tested at 11:35 a.M.And 11:35 a.M.With results of 337 mg/dl and 349 mg/dl.The customer thought the higher results were correct.None of the patients were treated based on the results.The same strip vial was used for all 3 patients.There was no allegation that an adverse event occurred due to the device.The customer stated qc results were within the acceptable range, however, the customer had used expired qc solution.The meter and test strips were requested for investigation.

Manufacturer Narrative

The customer returned meter for investigation.Retention samples glucose lot 289194-01 were measured with 3 edta blood and control solutions gkl60 lot316532-99 and gkl180 lot316531-99 on the customer meter and reference meters.Results from the customer's accutrend plus meter (after cleaning): 1).The mean of the measurements with the affected accutrend plus meter s/n rr0245848 is as follows: edta blood 1: 77 mg/dl 79 mg/dl 73 mg/dl.Mean value 76.3 mg/dl , edta blood 2: 195 mgdl 184 mg/dl 190 mg/dl.Mean value 189.7 mg/dl, edta blood 3: 293 mgdl 298 mg/dl 295 mg/dl.Mean value 295.3 mg/dl , gkl 60: 79 mg/dl 82 mg/dl 80 mg/dl.Mean value 80.3 mg/dl, gkl 180: 196 mg/dl 198 mg/dl 204 mg/dl.Mean value 199.3 mg/dl.Results from a retention accutrend plus meter: 2).The mean of the measurements with the retention accutrend plus meter is as follows: edta blood 1: 76 mg dl 74 mg dl 79 mg/dl.Mean value 76.3 mg/dl, edta blood 2: 198 mg/dl 193 mg/dl 199 mg/dl.Mean value 196.7 mg/dl , edta blood 3: 286 mg/dl 303 mg/dl 298 mg/dl.Mean value 295.7 mg/dl, gkl 60: 79 mg/dl 78 mg/dl 79 mg/dl.Mean value 78.7 mg/dl, gkl 180: 205 mg/dl 197 mg/dl 201 mg/dl.Mean value 201.0 mg/dl.All measurements on accutrend plus meter s/n (b)(4) and on the retention accutrend plus meter are within the specified control ranges.No differences between the customer instrument and retention instrument could be observed.No significant differences between accutrend plus meter s/n (b)(4) and the retention accutrend plus meter could be observed with the three edta blood samples.There are no significant differences between both accutrend devices (customer and reference/retention meters).Root cause of the questionable glucose results was a very contaminated and soiled accutrend plus instrument with blood.Also a scratch was found during the investigation.The problem which was alleged by the customer can only be explained by mishandling at customer side.After cleaning the returned accutrend plus meter s/n (b)(4) meter, all obtained results fulfill requirements.

Manufacturer Narrative

A routine retention testing process has been implemented.Valid retention results are available for all lots in the event a strip lot is alleged in a complaint.All retention data is reviewed on a monthly basis once testing is complete.If a failing result is observed during testing, appropriate actions will be taken.

Manufacturer Narrative

Only the customer's meter was returned for investigation.The customer device was very heavily contaminated with blood under the adapter.The field of view was also contaminated with blood and was scratched.After cleaning the customer meter, retention samples glucose lot 289194-01 were measured with 3 edta blood and control solutions gkl60 lot316532-99 and gkl180 lot316531-99 on the customer meter and reference meters.There was no significant differences between results from customer meter and reference meters and the results were within the tolerance range.Any differences was due to the heavy contamination of the device.

• 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
• MDR Report Key: 8577166
• MDR Text Key: 143959111
• Report Number: 1823260-2019-01662
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K952875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11447475160
• Device Lot Number: 28919401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1