MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-16 for ACCU-CHEK ? INFORM II TEST STRIPS 05942861001 manufactured by Roche Diagnostics.
[178240993]
The customer stated the test strip port was contaminated with control solution. Controls were run on both meters and passed. Meter a and the test strips were requested for investigation. The meter was returned. The test strips were not returned. Routine retention testing is performed. Retention testing data is reviewed and appropriate actions are taken as needed. The meter was tested using retention test strips and controls: control ranges: level 1 30-60 mg/dl, level 2 261-353 mg/dl. Results: level 1? 45, 45, 44 mg/dl. Level 2? 310, 314, 298 mg/dl. All returned results are within acceptable range. The meter was also disassembled and it's electronic compartment was visually inspected. Contamination was observed at the test strip port. This contamination can lead to the issue the customer complained about. The investigation did not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[178240994]
The initial reporter complained of discrepant glucose results for 1 patient tested on 2 accu-chek inform ii meters with serial numbers (b)(4) (meter a) and (b)(4) (meter b). At 5:44 p. M. The result from a finger stick on meter a was hi (result > 600 mg/dl). The operator did not believe this result. At 5:49 p. M. The result from a finger stick on meter b was 358 mg/dl. Based on viewing the patient's other test results, including blood gas, lab personnel believe the patient's glucose may actually have been that high.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2020-00149 |
| MDR Report Key | 9595678 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-21 |
| Date Mfgr Received | 2019-12-24 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-CHEK ? INFORM II TEST STRIPS |
| Generic Name | BLOOD GLUCOSE MONITORING TEST STRIPS |
| Product Code | LFR |
| Date Received | 2020-01-16 |
| Model Number | NA |
| Catalog Number | 05942861001 |
| Lot Number | 477719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |