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 2017-10-17 for COBAS 6000 CORE UNIT manufactured by Roche Diagnostics.
[90584669]
(b)(4). The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90584670]
The customer complained of a discrepant bilt3 bilirubin total gen. 3 (bilt3) result on one neonate patient. The initial bilt3 result was 508. 5? Mol/l. The patient had phototherapy along with a glucose infusion started based on this initial result. The physician did not believe the initial result and requested the sample to be retested along with having another blood sample drawn. The repeat bilt3 result from the original sample was 290? Mol/l. The redraw sample also had a bilt3 result of <300? Mol/l. The repeat result was deemed to be correct and the glucose infusion and phototherapy were stopped. There was no allegation that the patient was adversely affected and was released and sent home. The reagent lot and expiration date for the bilt3 was requested but not provided. Other testing that was performed concurrently with the initial bilt3 testing had a sample alarm that is often associated with a pipetting error caused by a clot. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02345 |
| MDR Report Key | 6954179 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-17 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-10-17 |
| 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 | 0 |
| 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 CORE UNIT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MQM |
| Date Received | 2017-10-17 |
| Model Number | COBAS 6000 CORE |
| Catalog Number | ASKU |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |