MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-21 for COBAS 6000 CORE 05036453001 manufactured by Roche Diagnostics.
[1951230]
The user received questionable carbamazepine results for three patient samples after an issue with calibration and quality control. Of the data provided, the result for one patient sample was discrepant. The user ordered calibration and quality control for a new reagent cassette and the reagent cassette already in use. However, the user stated the instrument calibrated only the new reagent cassette and only ran quality control on the reagent cassette already in use. The patient samples were initially tested at this time and the results reported outside the laboratory. The user discovered the calibration had failed as the calibrator material had been loaded in reverse order. However, the user said the instrument did not flag the calibration or alert them that the calibration failed. On (b)(6) 2011, they recalibrated a new reagent cassette, ran quality control and repeated the patient samples. For the one patient sample, the initial result was 2. 111 ug/ml and the repeat result was 3. 396 ug/ml which was entered as a corrected result in the host system. The user did not think there was any affect to this patient because the result was corrected within five hours. The carbamazepine reagent lot number was 63541701. The field application specialist determined the system software was not working as the user expected. She discussed the procedures they were following and determined they appeared to be correct as described for the cobas 6000 software. She found the user was not following the maintenance schedule for instrument shutdown and they were not deleting quality control results.
Patient Sequence No: 1, Text Type: D, B5
[9114274]
.
Patient Sequence No: 1, Text Type: N, H10
[9200441]
The investigation determined the analyzer and software performed as designed. Further investigation could not be performed as the user could not provide any information about the software with regards to the quality control not being performed after the calibration. As the issue was not reproducible, the investigation was closed as not confirmed. Falsely low results can lead to unnecessary administration of medication or an elevation of dosage. However in this event, as the correct result was also below the therapeutic range the patient may have received the medication regardless. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02178 |
| MDR Report Key | 2065745 |
| Report Source | 05,06 |
| Date Received | 2011-04-21 |
| Date of Report | 2011-07-07 |
| Date of Event | 2011-04-02 |
| Date Mfgr Received | 2011-04-04 |
| Date Added to Maude | 2011-04-21 |
| 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 RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KLT |
| Date Received | 2011-04-21 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| 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 | 2011-04-21 |