MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2014-06-24 for ACCU-CHEK ? AVIVA COMBO manufactured by Roche Diagnostics.
[4671974]
Caller reported display of meter has several thin vertical lines. Caller stated measurement results were not affected. Preliminary evaluation found the meter for display defect; two thin and one thick line appear on the middle of the meter screen. Evaluation found that the location of the line on the display does distort the digit during the simulation test, therefore misinterpretation is possible. No adverse event reported. Requested return of the alleged meter for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[12106198]
The event occurred in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-04627 |
| MDR Report Key | 3891133 |
| Report Source | 00,01,07 |
| Date Received | 2014-06-24 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-05-30 |
| Date Added to Maude | 2014-06-24 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 | SANMINA-SCI CORPORATION |
| Manufacturer Street | MEDICAL PLANT 438 13000 SOUTH MEMORIAL PARKWAY |
| Manufacturer City | HUNTSVILLE AL 35807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 35807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-CHEK ? AVIVA COMBO |
| Generic Name | BLOOD GLUCOSE MONITORING DEVICE |
| Product Code | CGD |
| Date Received | 2014-06-24 |
| Returned To Mfg | 2014-05-16 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | 00700006578 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-24 |