MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-12 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[1522229]
The user received discrepant hcg results for one patient sample. The original result was 143. 1 miu/ml. The doctor called to request the sample be rerun. The repeat result was 7818 miu/ml. A (b) (6) hospital ran the same sample and received a result of 8000 miu/ml. The patient was not treated based on the original result because the patient was in the er and the doctor suspected pregnancy. The hcg reagent lot number was 15548403 the user refused a service visit because they believed the issue to be sample related.
Patient Sequence No: 1, Text Type: D, B5
[1549218]
On (b)(6)2010, pt contacted the office. Pt noticed painful nodules on right nlf - don't know when they started. Pt was injected with hyaluronidase on (b)(6)2010.
Patient Sequence No: 1, Text Type: D, B5
[8647330]
Data provided indicates calibration signals of calibrator two were lower than expected. Quality controls were within range. A reagent issue appears unlikely. No assay performance data or instrument maintenance information was available for further investigation. No conclusion regarding instrument performance is possible. Based upon the information provided, it was determined the low results were most likely caused by a pre-analytic issue. The user believes the issue may have been due to a short sample. The user poured the sample into a cup. This is not recommended and could cause foam or bubbles on samples, which in turn could cause low results.
Patient Sequence No: 1, Text Type: N, H10
[8663923]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-02147 |
| MDR Report Key | 1656326 |
| Report Source | 05,06 |
| Date Received | 2010-04-12 |
| Date of Report | 2010-05-20 |
| Date of Event | 2010-03-22 |
| Date Mfgr Received | 2010-03-23 |
| Date Added to Maude | 2010-05-20 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | MEDICAL TECHNOLOGIST |
| 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 |