MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-19 for COBAS 311 04826876001 manufactured by Roche Diagnostics.
[4022810]
The customer reported that they have been getting intermittent low ion selective electrode (ise) potassium results since approximately (b)(6) 2013. The customer stated that the issue has occurred multiple times with multiple patient samples. The customer was asked, but could not provide an exact number of how many patient samples were affected. The customer was also asked, but could not provide any specific sample results. The customer ran comparisons with another laboratory and the difference in results was 0. 6 to 0. 8 mmol/l. The initial results from this laboratory were lower and the repeat results from the other laboratory were believed to be correct. Initial results would be below the normal range of 3. 4 mmol/l to 4. 5 mmol/l. Repeat results were within the normal range. The original results for multiple samples were reported outside of the laboratory. The patients were not adversely affected. The ise potassium electrode lot number and expiration date were asked for, but not provided. The customer stated that they tried replacing the electrodes, reconditioning the electrodes, and increasing the calibration and quality control frequency, but the issue persisted. The field service representative determined that the vacuum pump diaphragm was damaged. He replaced the vacuum pump diaphragm. Precision studies, calibration, and quality controls were performed. All controls were acceptable to the customer and the system was found to be operating within specifications.
Patient Sequence No: 1, Text Type: D, B5
[11334098]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11357609]
The customer indicated that the most recent event occurred on (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
[11401263]
A specific root cause could not be determined based on the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-07095 |
| MDR Report Key | 3476932 |
| Report Source | 05,06 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-12-06 |
| Date of Event | 2013-07-01 |
| Date Mfgr Received | 2013-11-06 |
| Date Added to Maude | 2013-11-19 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| 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 311 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2013-11-19 |
| Model Number | NA |
| Catalog Number | 04826876001 |
| 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 | 2013-11-19 |