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 2016-08-17 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[52393119]
(b)(6). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[52393120]
The customer received a questionable total hemoglobin (thb) result for one patient when compared to another cobas b221 analyzer and the result from a cobas 8000 analyzer in the laboratory. The result from cobas b221 serial number (b)(4) was 5. 1 g/dl. The result from cobas b221 serial number (b)(4) was 9. 4 g/dl. The result from the laboratory analyzer was 7. 8 g/dl and was believed to be correct. Information concerning if the erroneous result was reported to a person treating the patient was requested, but it was unknown. It was noted a nurse performed the thb testing on the analyzer. The patient was not harmed as only the results from the laboratory were used for patient treatment. The lot number and expiration date of the thb cuvette was requested, but was not provided. On (b)(6) 2016, the field service representative performed testing with a fresh blood sample from the same patient and the results were: cobas b221 serial number (b)(4): 8. 0 g/dl and 8. 1 g/dl. Cobas b221 serial number (b)(4): 8. 1 g/dl and 8. 1 g/dl. The result from the cobas 8000 analyzer was 7. 8 g/dl.
Patient Sequence No: 1, Text Type: D, B5
[54061392]
Based on the provided data, the issue was most likely caused by air bubbles in the sample or cuvette of the coox module during testing. It is not possible to clearly identify the origin of these bubbles. There was a possibility that the bubbles could have been generated by the system, but no systematic occurrence of bubbles was observed within the data. The air bubbles might have also been caused in the pre-analytic processing of the sample. The investigation of all of the provided instrument data showed no system related problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01224 |
| MDR Report Key | 5883514 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-17 |
| Date of Report | 2018-04-04 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2016-08-08 |
| Date Added to Maude | 2016-08-17 |
| 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 | 2016-08-17 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | NURSE |
| Device Availability | * |
| 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 | 2016-08-17 |