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 2014-12-23 for COBAS B 221 6 ROCHE OMNI S6 SYSTEM 03337154001 manufactured by Roche Diagnostics.
[5112216]
The customer reported that they have been having problems with lactate on the cobas b221 analyzer. The customer has found a difference in lactate results when comparing results from this cobas b221 analyzer to another one in the laboratory. They have found that there is a difference of 0. 5 mmol/l on the low side of the lactate measuring range. Their control recovery has also shown a negative bias on recent occasions. The customer also stated that there were occasions where they have had results below the measuring range and when repeated on the cobas b 221 analyzer in the laboratory, they get an actual value such as 0. 5 mmol/l. The issue was initially thought to be due to fluidics. An engineer has performed all required maintenance, but it has not resolved the issue. The customer only provided examples of results from a total of three patients. Of these three patients, one had erroneous results. The patient was initially tested 3 times, giving values of 0. 4 mmol/l, 0. 5 mmol/l, and 0. 7 mmol/l. When tested on the laboratory analyzer, the result was 0. 9 mmol/l. It is unknown if these results were reported outside of the laboratory or used for diagnostic purposes. It is unknown if any patients were adversely affected. This information was requested but not provided. No adverse events were alleged. The lactate cartridge lot number and expiration date were requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[12723643]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[15766083]
The date of the event has been confirmed to be (b)(6) 2014. Initial reporter name and country has been updated. Initial reporter occupation has been updated. It was confirmed that no patients were adversely affected due to the event. The repeat result of 0. 9 mmol/l from the laboratory instrument was reported outside of the laboratory. The repeat result was generated from the same sample as the initial results. The patients were all adults. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[33873563]
A specific root cause could not be determined based on the provided information. Additional information required for investigation was requested, but not provided. The calibration signals for lactate show normal behavior and do not hint towards a sensor or system problem. An analysis of the system database did not reveal any indications that the reported results could be caused by a malfunction of the system. It was noted that the mss sensor which was on board at the time of the reported measurements, was installed at the customer site without reading of the bar code. This means that the sensor was not installed as specified and all information regarding the lot number and expiration date was not recovered in the software. As a consequence, the wetting routine would not have been started automatically by the software and the on board time of the sensor also would not have been counted by the software.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-10386 |
| MDR Report Key | 4356462 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-23 |
| Date of Report | 2015-03-24 |
| Date of Event | 2014-12-07 |
| Date Mfgr Received | 2014-12-07 |
| Date Added to Maude | 2014-12-23 |
| 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 6 ROCHE OMNI S6 SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2014-12-23 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-23 |