MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2015-04-22 for COBAS B 221 6 ROCHE OMNI S6 SYSTEM 03337154001 manufactured by Roche Diagnostics.
[20153603]
The customer reported that they had been getting implausible ph measurement results for an unspecified number of patient samples. For example, the analyzer will measure ph values of 7. 5 to 7. 6 for a sample. When a sample is measured on a different analyzer, the ph result will be 7. 4. Data was provided for a total of two patient samples. Erroneous results were reported outside of the laboratory. Please refer to the attachments for sample results from each patient. Each printout on the attachment represents results from a different sample of the same patient. The second patient is a (b)(6) female born on (b)(6) 1939 and weighing (b)(6). The patients were not adversely affected. The ph electrode lot number and expiration date were asked for, but not provided. The field service engineer identified the measuring chamber as the cause of the issue. He changed the measuring chamber. After changing the chamber, quality control measurements and comparative measurements were correct.
Patient Sequence No: 1, Text Type: D, B5
[20464240]
This event occurred in (b)(6). Results - device subassembly = measuring chamber.
Patient Sequence No: 1, Text Type: N, H10
[22562526]
A specific root cause could not be identified. The measuring chamber module was provided for investigation and the issue could not be reproduced. The customer changed the ph electrode prior to the field service visit. Quality control data suggests there may have been a problem with the ph electrode. The lot number of the electrode was not available. No further investigation could be performed on this electrode. It was noted the customer only runs one level of quality control. It is recommended to complete a quality control test on three levels after each electrode exchange, after each exchange of solutions and packs and after startup of the instrument. The customer did not follow the recommended roche qc concept and ran only 1 quality material to check the instrument performance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03209 |
| MDR Report Key | 4718957 |
| Report Source | 01,06,07 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-07-28 |
| Date of Event | 2015-03-31 |
| Date Mfgr Received | 2015-04-02 |
| Date Added to Maude | 2015-04-22 |
| 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 | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS B 221 6 ROCHE OMNI S6 SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2015-04-22 |
| 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 | 2015-04-22 |