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 2014-04-11 for COBAS B 221<6>=ROCHE OMNI S6 SYSTEM 03337154001 manufactured by Roche Diagnostics.
[4421650]
The customer alleged they received questionably low total hemoglobin results on their b221 analyzer. The customer provided data for one patient with a discrepant result. The patient's initial total hemoglobin result was 8. 7 g/dl and it was reported to the physician. The customer stated that in the "pediatric intensive room", the doctors complained that the value of total hemoglobin was very low and should be around 13 g/dl. The sample was repeated with a sysmex hematology automated analyzer, model xe2100. The repeat result was 12 g/dl. The patient was not adversely affected by this event. The total hemoglobin cartridge lot number and expiration date were requested but not provided. During the evaluation of the analyzer, it was found that there was a layer of brown color on the walls of the cuvette. The cleaning procedure was done, but the low results were still present. An automatic cleaning every 20 samples was initiated, but the problem persisted. The cuvette was replaced and calibration was performed. After replacing the cuvette, the hemoglobin results came back to the normal range.
Patient Sequence No: 1, Text Type: D, B5
[11790972]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[12125717]
The contamination found on the cuvettes was probably due to residual blood or micro clots that could not be washed out. During the investigation, there was information suggesting the quality control concept was not properly applied by the customer. Two contaminated cuvettes were returned by the customer for investigation and produced quality control measurement alarms when tested. The customer's quality control verification should have warned the customer about the state of the system, if it was properly applied. Properly applying the quality control concepts allow the customer to detect these contaminations earlier and adjust their cleaning protocols. No hints of an instrument based error could be observed. No general cuvette problems have been reported. The instrument has been removed from the laboratory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-02591 |
| MDR Report Key | 3745842 |
| Report Source | 01,05,06 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-07-08 |
| Date of Event | 2014-03-18 |
| Date Mfgr Received | 2014-03-18 |
| Date Added to Maude | 2014-04-11 |
| 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 | 2014-04-11 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | PHYSICIAN |
| 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 | 2014-04-11 |