MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-03-17 for COBAS 6000 CORE 04745868001 manufactured by Roche Diagnostics.
[18411669]
The user received questionable immunoglobulin igg generation 2 (igg) results for one patient. The initial result was 861 mg/dl. The repeat results on (b)(6) 2011 were 279 mg/dl using an aliquot tested on the cobas c501 analyzer, 759 mg/dl on the cobas integra 800 analyzer and 710 mg/dl on the cobas c501 analyzer. It was unknown if the patient was adversely affected. No adverse events were reported. The igg reagent lot number was 633089. The investigation was not able to determine a specific root cause due to insufficient data.
Patient Sequence No: 1, Text Type: D, B5
[18690788]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-01453 |
| MDR Report Key | 2022203 |
| Report Source | 01,05,06 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-03-17 |
| Date of Event | 2011-01-25 |
| Date Mfgr Received | 2011-02-23 |
| Date Added to Maude | 2011-03-17 |
| 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 RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| 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 | KTO |
| Date Received | 2011-03-17 |
| Model Number | NA |
| Catalog Number | 04745868001 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-17 |