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 2010-12-15 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[8945022]
A specific root cause was not identified. A general instrument problem, assay problem, or handling problem could not be identified. Results were not reported outside the laboratory or to the physician.
Patient Sequence No: 1, Text Type: N, H10
[19932189]
The customer received questionable cortisol results for one patient sample. The same sample was tested six times during three different days. The initial results were 49 nmol/l, 77 nmol/l and 91 nmol/l. The sample was repeated on (b)(6) 2010 and recovered 94 nmol/l and 119 nmol/l. The sample was repeated on (b)(6) 2010 and recovered 113 nmol/l. Results were not reported outside the laboratory and were not reported to the physician. The laboratory physician contacted the patient's doctor. The patient was not harmed by any action taken and the patient's current condition is good. The cortisol reagent lot number was 15879801.
Patient Sequence No: 1, Text Type: D, B5
[20098575]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07454 |
| MDR Report Key | 1927172 |
| Report Source | 01,05,06 |
| Date Received | 2010-12-15 |
| Date of Report | 2011-01-04 |
| Date of Event | 2010-11-28 |
| Date Mfgr Received | 2010-12-03 |
| Date Added to Maude | 2011-04-08 |
| 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 ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| 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 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CGR |
| Date Received | 2010-12-15 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| 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 | 2010-12-15 |