MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-07-30 for COBAS 6000 CORE 04745868001 manufactured by Roche Diagnostics.
[1568521]
The customer received questionable results for alkaline phosphatase (alp) on the cobas 6000 core analyzer for one patient sample. The initial result for alp was 411 u/l. This result was flagged with a delta check by the customer's laboratory information system. The sample was repeated which gave a result of 140 u/l. The customer could not reproduce the initial result for alp. The initial result was not reported outside the laboratory. The patient was not treated based on the initial result. Calcium reagent lot number, 622035.
Patient Sequence No: 1, Text Type: D, B5
[1688151]
Device 2 of 2. Reference mfr report: 1627487-2010-02425.
Patient Sequence No: 1, Text Type: D, B5
[8791440]
It is unknown if initial reporter sent report to fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[8889901]
Investigation of the data provided indicated a possible cause for the high alp result was carry-over of particulates, such as fibrin clots or leukocytes, by the sample probe. These particulates may have been present because of the short sample centrifugation time used by the customer. The tube manufacturer recommends spinning the sample for at least 10 minutes, the customer was only spinning samples for 7 minutes. The patient was not affected by the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-04557 |
| MDR Report Key | 1778052 |
| Report Source | * |
| Date Received | 2010-07-30 |
| Date of Report | 2010-11-08 |
| Date of Event | 2010-07-21 |
| Date Mfgr Received | 2010-07-21 |
| Date Added to Maude | 2010-11-08 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| 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 |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJO |
| Date Received | 2010-07-30 |
| Catalog Number | 04745868001 |
| 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 INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-30 |