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 2014-03-03 for COBAS B 221<6>=ROCHE OMNI S6 SYSTEM manufactured by Roche Diagnostics.
[12261470]
A root cause could not be determined with the information provided. Additional data were requested but not provided. The customer's hardware was not available for an investigation. The production data and batch records were reviewed; no deviations related to the customer's observations could be identified. The investigation of the provided data from the customer did not show any evidence of an instrument, consumables, or system malfunction. It was noted the customer was not following the manufacturer's recommendations for performing quality control.
Patient Sequence No: 1, Text Type: N, H10
[18866672]
The customer alleged they received questionable ph, pco2, po2, hco3, be, and potassium results on their cobas b221 analyzer. The customer alleged there were patient results that did not correlate well between this analyzer and another b221 analyzer, serial number (b)(4). The customer provided data for 18 patients, 15 of which had discrepant results. The customer stated that the initial ph and be results for patient 1 were reported outside the laboratory. The ward staff queried the initial results based on the patient's clinical presentation. The repeat results from the second analyzer better fit patient's presentation. Information on whether any of the other results were reported outside the laboratory was requested but not provided. The units of measure were requested but not provided. There were no adverse events. The electrode lot number and expiration date were requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[19129801]
This event occurred in (b)(6). The specific part number involved in this event was requested but not provided. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-01470 |
| MDR Report Key | 3655846 |
| Report Source | 01,05,06 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-08-21 |
| Date of Event | 2014-02-06 |
| Date Mfgr Received | 2014-02-06 |
| Date Added to Maude | 2014-03-03 |
| 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 | COBAS B 221=ROCHE OMNI S6 SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2014-03-03 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-03 |