MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-31 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[86281003]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[86281004]
The customer obtained a questionable low result for one neonate patient sample using the bilt3 bilirubin total gen. 3 (bilt3) assay on the cobas 6000 c (501) module. All result are in units of umol/l. The initial result was released outside the laboratory. No data flags or alarms occurred. The initial result from a microcup was 13. 1. The clinician rejected this result and asked for it to be repeated. The repeat result was 286. 1. The sample's appearance made this result more plausible. There was no allegation that an adverse event occurred. The bilt3 reagent lot number was 221231 with an expiration date of 10/30/2018. Calibration and quality controls were acceptable; therefore, a general reagent issue could be excluded. The customer has not had issues with any other assays. The field service representative checked the cell wash settings, sodium hydroxide consumption, carry-over settings, gear pump pressure, tubing installation, and sample and reagent needle wash; all were acceptable. He ran a precision check which passed. The alarm log showed no issues. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. The most likely root cause was an isolated sample-related issue. The issue did not recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01875 |
| MDR Report Key | 6835067 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-31 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2017-08-14 |
| Date Added to Maude | 2017-08-31 |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MQM |
| Date Received | 2017-08-31 |
| Model Number | C501 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-31 |
| Model Number | C501 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-31 |