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 2017-03-01 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[68766224]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68766225]
The customer stated that they received an erroneous result for one newborn patient sample tested for bilirubin on a cobas b 221<6>=roche omni s6 system (b221). The issue was encountered only with this one sample. A capillary sample from the patient was tested on the b221 analyzer, resulting as 16. 3 mg/dl. After this high result, the customer prepared 3 additional samples from the patient; one capillary sample for testing on the b221 analyzer, one for testing on a bilirubinometer, and one venous sample for testing in the central laboratory. The sample tested on the bilirubinometer resulted as 12. 7 mg/dl. The sample tested in the central laboratory resulted as 13. 57 mg/dl. The sample tested on the b221 analyzer confirmed the previous high result of 16. 3 mg/dl. All controls recovered ok. It was also stated that the "cuvette" was replaced and calibrated, with controls recovering ok. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[69978578]
Patient Sequence No: 1, Text Type: N, H10
[71848256]
Patient Sequence No: 1, Text Type: N, H10
[75261211]
Data provided from the analyzer showed no indication of analyzer related problems. There were no indications in the calibration data of an analyzer related problem. All quality control results were within range and did not indicate an analyzer related problem. The issue was determined to be related to a pre-analytic sample handling issue. No other issues with bilirubin on the cobas b221 analyzer have been reported within the past year.
Patient Sequence No: 1, Text Type: N, H10
[78487057]
Based upon medical assessment, all results that were obtained indicated hyperbilirubinemia. In newborns older than 3 days, only levels >20mg/dl or >25mg/dl are likely to lead to immediate phototherapy or consideration of exchange transfusion. No medical risk is likely in this case.
Patient Sequence No: 1, Text Type: N, H10
[132589492]
Medwatch has been updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00442 |
| MDR Report Key | 6369981 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-01 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-02-11 |
| Date Added to Maude | 2017-03-01 |
| 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 | 2017-03-01 |
| 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 | 2017-03-01 |