MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-02-27 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[101485922]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[101485923]
The customer stated that they received erroneous results for five patient samples tested for potassium (k+) and calcium (ca2+) on a cobas b 221<6>=roche omni s6 system (b221). The erroneous results for the second through fifth samples were not reported outside of the laboratory to the attending physician. It was asked, but it is not known if an erroneous result was reported outside of the laboratory for the first sample. The customer has not received any complaints about additional erroneous results from physicians. The first sample initially resulted with a k+ value of 6. 05 mmol/l accompanied by a data flag. The sample was repeated on the same analyzer, resulting with a k+ value of 3. 52 mmol/l. This sample initially resulted with a ca2+ value of 1. 070 mmol/l accompanied by a data flag and when repeated on the same analyzer, it resulted as 1. 180 mmol/l. The second sample initially resulted with a k+ value of 11. 86 mmol/l. The sample was repeated on a second b221 analyzer, resulting with a k+ value of 3. 22 mmol/l. The third sample initially resulted with a k+ value of 5. 72 mmol/l. The sample was repeated on a second b221 analyzer, resulting with a k+ value of 3. 08 mmol/l. The fourth sample initially resulted with a k+ value of 5. 27 mmol/l. The sample was repeated on a second b221 analyzer, resulting with a k+ value of 3. 26 mmol/l. The fifth sample initially resulted with a k+ value of 6. 5 mmol/l. The sample was repeated on a second b221 analyzer, resulting with a k+ value of 3. 80 mmol/l. No adverse events were alleged to have occurred with the patients. There have been no alarms generated on the analyzer. The analyzer is new. Quality controls have been in range. All samples were mixed on an agitator for 10 minutes prior to the first measurement. The samples were then placed back on the agitator and then repeated 15 minutes later. The k+ and ca2+ electrode/cartridge lot numbers and expiration dates were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00572 |
| MDR Report Key | 7299088 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-27 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-05 |
| Date Added to Maude | 2018-02-27 |
| 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 | ROCHE OMNI S |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2018-02-27 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-02-27 |