MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-09-18 for ANALYTICAL P MODULE 03261603001 manufactured by Roche Diagnostics.
[1176756]
The user received discrepant calcium results for several pt samples. The samples were all drawn in bd tubes (b) (4) sst 7. 5 ml with gel separator. Three examples were provided. All results are in mg/dl. Sample 1 initial result was 7. 4 and was accompanied by a data flag alerting the user the result met repeat criteria defined by the user. The same sample was repeated, and a result of 8. 5 was received. Sample 2 initial result was 8. 2 and the first repeat result was 6. 9. Both results were accompanied by data flags alerting the user the result met repeat criteria defined by the user. The sample was repeated again and a result of 8. 4 was received. Sample 3 initial result was 7. 5, first repeat result was 6. 6 and second repeat result on (b) (6)2009, was 7. 4. All three results were accompanied by data flags alerting the user the result met repeat criteria defined by the user. The sample was repeated again on (b) (6)2009, and a result of 7. 3 was received accompanied by the same data flag. No erroneous results were reported.
Patient Sequence No: 1, Text Type: D, B5
[8403723]
The field service rep was unable to determine a cause. He replaced the reagent probes and noted the r2 stirrer had a substance on it and a small chip on the edge. He performed checks on the fluidic pressures, vacuum and probe alignments, high concentration waste valves, tubings, rinse nozzles and squeegees. To verify the analyzer operation, he ran a precision with acceptable results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2009-06230 |
| MDR Report Key | 1502910 |
| Report Source | 05,06 |
| Date Received | 2009-09-18 |
| Date of Report | 2009-09-18 |
| Date of Event | 2009-08-29 |
| Date Facility Aware | 2009-09-02 |
| Report Date | 2009-09-02 |
| Date Mfgr Received | 2009-09-02 |
| Date Added to Maude | 2009-12-15 |
| 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 RD. |
| 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 Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANALYTICAL P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER -JJE |
| Product Code | JFP |
| Date Received | 2009-09-18 |
| Model Number | P MODULE |
| Catalog Number | 03261603001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-18 |