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 2016-02-29 for OMNI 03337154001 manufactured by Roche Diagnostics.
[39311139]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[39311140]
The customer questioned results for 1 patient tested for potassium (k+) when comparing the b 221 instrument to the result from the laboratory. The initial k+ result from the b 221 instrument was 7. 71 mmol/l. A 2nd sample was obtained the same day and the result from the laboratory was 3. 8 mmol/l. Repeat testing was performed at 3:00 p. M. And the k+ results correlated well. It is not known if an adverse event occurred. No adverse event was reported. The k+ electrode lot number and expiration date was not provided. The customer indicated that calibration and quality controls were acceptable at the time of the high result. It was also noted that there had been only this one instance of a high potassium result.
Patient Sequence No: 1, Text Type: D, B5
[43614001]
It was clarified that no adverse event occurred. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on a review of the available data, the lot number of the k electrode used during the event was 21553348, however, this could not be confirmed by the customer. Calibration data was acceptable. No instrument issues were identified. The root cause may be related to pre-analytical issues such as hemolysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00230 |
| MDR Report Key | 5467802 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-29 |
| Date of Report | 2018-04-04 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-02-05 |
| Date Added to Maude | 2016-02-29 |
| 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 | 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 | OMNI |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2016-02-29 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-29 |