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 2017-06-19 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[77844231]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[77844232]
The customer received questionable total hemoglobin results for an unknown number of patient samples. Clarification of the specific data for the event was requested but could not be provided. Provided were questionable results for multiple assays for one patient that occurred on (b)(6) 2017. The specific data was unclear. Clarification was requested but was not provided. Refer to the attachment to the medwatch for the provided patient data. Information was provided as "a patient has been treated because of these false values". Specific information regarding the treatment was not provided. It was unknown if the patient was adversely affected. The reagent lot numbers and expiration dates were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
[132597387]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on the calibration and qc database, there was no indication of an issue with the thb parameter. The provided instrument database contained errors on the date of the event but since the exact time of the event was not known, a connection could not be assessed. As the thb assay requires special sample handling as documented in product labeling, preanalytical issues may have caused or contributed to the issue.
Patient Sequence No: 1, Text Type: N, H10
[132606211]
Medwatch - product code was updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01266 |
| MDR Report Key | 6649587 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-19 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-06-02 |
| Date Added to Maude | 2017-06-19 |
| 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 | 2017-06-19 |
| 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 | 2017-06-19 |