MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-04-12 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[1295058]
The application specialist reported a specimen for hcg was processed through the mpa aliquoter and sent in a sample cup to the e601 analyzer. The initial result was 0. 881 miu/ml and was released to the physician who questioned the result because of the patient's previous results. The primary tube was repeated on the e170 analyzer where it recovered 2754 miu/ml. The result was corrected in the lis to reflect this. The patient was not harmed based on the initial result. The hcg reagent lot number was 15548403. The field service representative could not find a cause and could not duplicate the problem. He visually checked and observed the operation of the instrument. To verify the analyzer operation, he performed a precision check with results meeting guidelines.
Patient Sequence No: 1, Text Type: D, B5
[8664398]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[17393398]
Account alleged the pt reported that the head section was elevated to approximately 45 degrees and moved downward to the lowest position. Account reported that there was no injury.
Patient Sequence No: 1, Text Type: D, B5
[17642037]
Investigation of the event determined the issue might have been caused by an operator handling error. There is no possibility for the mpa to add water to an aliquote as the aliquoter can only pipette out of the primary tube due to an air filled pipetting system. Most likely the water was contained in the aliquot tubes before pipetting started and the serum was added by the aliquoter. A reagent-related issue is unlikely because both the falsely low and the expected results were generated on tests using the same reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-02144 |
| MDR Report Key | 1656385 |
| Report Source | 05,06,07 |
| Date Received | 2010-04-12 |
| Date of Report | 2010-06-09 |
| Date of Event | 2010-03-23 |
| Date Mfgr Received | 2010-03-23 |
| Date Added to Maude | 2010-06-09 |
| 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 | NAL |
| Date Received | 2010-04-12 |
| 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 | 2010-04-12 |