MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-26 for COBAS 4000 C (311) STAND ALONE SYSTEM C311 04826876001 manufactured by Roche Diagnostics.
[78398420]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78398421]
The customer obtained questionable high test results for three patient samples using the ureal urea/bun (bun) assay on the cobas 4000 c (311) stand alone system (c311). The physician questioned all results, and the samples were sent to another laboratory where the results were "normal. " of the three samples, only the result data for one sample was provided. All results are in units of mg/dl, and all were released outside of the laboratory. The initial result was 55. The physician questioned the result, so the sample was sent to another laboratory. The result from the second laboratory's roche c6000 instrument was 15. On (b)(6) 2017, the customer recalibrated the bun assay and repeated the sample on their c311. The result was 15. Both results of 15 were deemed correct. No adverse event occurred. The bun reagent lot number is 21831701 with an expiration date of 10/31/2017. After the event, the customer continued to test bun on their c311, and was performing qc on the assay twice per day. The field service representative found that the sample probe was not aligned properly over the rinse station which prevented the probe from getting a proper outside rinse. He performed a sample probe alignment over the rinse station, check all other alignment positions, and checked the rinse mechanism for proper fluidics function. Qc was acceptable, and the customer would run qc every four hours to monitor. The customer did not feel that a sample probe misalignment issue was the cause. The customer agreed the bun reagent had been on-board the analyzer for two weeks and the calibration curve could have drifted out of specification. After the assay was recalibrated, the issue seemed to resolve. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
[132607943]
The customer did not feel that the issue was caused by the misaligned sample probe, nor that the previous service activities resolved the issue. The customer believed that the calibration curve had drifted and the assay needed recalibrated. The customer recalibrated the assay and they stated that the issue resolved. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01332 |
| MDR Report Key | 6666292 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-26 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-06-09 |
| Date Mfgr Received | 2017-06-12 |
| Date Added to Maude | 2017-06-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | 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 4000 C (311) STAND ALONE SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-06-26 |
| Model Number | C311 |
| 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 | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 4000 C (311) STAND ALONE SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-26 |
| Model Number | C311 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-26 |