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 2018-03-09 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[102218688]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[102218689]
The customer received a questionable total hemoglobin (thb) result for one patient with a cobas b221 analyzer when compared to a xn 1000 hematology instrument. Of the data provided, there were erroneous results for the thb and hematocrit (hct) tests. The thb result from the cobas b 221 was 5. 45 g/dl. The thb result using the same sample in another laboratory with an xn 1000 instrument was 9. 60 mg/dl. The hct result from the b 221 was 15. 0%. The hct result using the same sample in another laboratory with an xn 1000 instrument was 29. 50%. The customer stated they observed this same issue with a different sample on (b)(6) 2018. No erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The qc results were checked and determined to be acceptable. The customer stated that they used "factory heparinized syringes". The lot number and expiration date of the thb cuvette was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00734 |
| MDR Report Key | 7326478 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-09 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-02-20 |
| Date Added to Maude | 2018-03-09 |
| 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 | ROCHE OMNI S |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2018-03-09 |
| 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 | 2018-03-09 |