MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-05-05 for OMNI 03337154001 manufactured by Roche Diagnostics.
[5822143]
The customer complained that the instrument printed incomplete results when running reports. The customer repeated the printing and the results still appeared incomplete. The customer obtained the results from the instrument screen and manually completed the reports. The issue occurred several times before the printer module was replaced. It is unclear how many times this occurred. One patient's glucose result was affected. It is unclear if any erroneous results were reported outside of the laboratory. No adverse event occurred. The printer module was replaced by the field service engineer on 04/09/2015. The affected printer module serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13454084]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[32500722]
The customer sent in printer module with serial number (b)(4) for investigation. No damage was identified during the visual inspection. A few heating pixels on the heating comb of the printer module were identified as being defective. The specific root cause of this defect could not be identified. The printouts showed that the first decimal place or the last digit of parameter results only partially readable or not readable, however the measurement results can be checked and compared via instrument screen and measurement database, where the results displayed correctly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03414 |
| MDR Report Key | 4750350 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-05 |
| Date of Report | 2015-06-11 |
| Date of Event | 2015-04-03 |
| Date Mfgr Received | 2015-04-08 |
| Date Added to Maude | 2015-05-05 |
| 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 |
| 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 | 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 | OMNI |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2015-05-05 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-05 |