MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-07-10 for OMNI 03337154001 manufactured by Roche Diagnostics.
[22390337]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[22390338]
A nurse at the customer site complained of erroneous results for 1 patient sample tested for thb and hct on the b221 analyzer located in the intensive care unit (icu). The initial thb result was 15. 6 g/dl. The repeat thb result 5 minutes later was 8. 4 g/dl. The initial hct result 42. 7%. The repeat hct result 5 minutes later was 19. 0%. A complete blood count (cbc) was run at this time and the thb result was 9. 5 g/dl and the hct result was 27. 6%. No adverse event was reported. The patient has been moved out of the icu. Quality controls were acceptable. The customer monitored samples being measured on the analyzer the day after the event and no abnormal results occurred.
Patient Sequence No: 1, Text Type: D, B5
[22561791]
A specific root cause could not be identified. A general instrument related issue can be excluded. A potential sample related issue was identified. The nurse did not mix the sample again before it was analyzed. The root cause may be related to a pre-analytic issue such as sedimentation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03793 |
| MDR Report Key | 4906581 |
| Report Source | 01,05,06 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-08-04 |
| Date of Event | 2015-06-22 |
| Date Mfgr Received | 2015-06-22 |
| Date Added to Maude | 2015-07-10 |
| 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 | 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 | 2015-07-10 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | NURSE |
| 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 | 2015-07-10 |