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 D MODULE 03449866001 manufactured by Roche Diagnostics.
[1239103]
User experiencing a downward shift in calcium results for approx 30 pt samples. The following four pt examples provided were discrepant. Repeat testing was performed on a different d module. Sample 1, initial result gave 1. 3 mg per dl. This result was accompanied by a data flag alerting the use the result was under the normal value limit. Repeat for this sample gave 8. 9 mg per dl. Sample 2 initial result gave 1. 1 mg per dl. This result was accompanied by a data flag alerting the use the result was under the normal value limit. Repeat for this sample gave 9. 3 mg per dl. Sample 3, initial result gave 4. 9 mg per dl. This result was accompanied by a data flag alerting the use the result was under the normal value limit. Repeat for this sample gave 9. 0 mg per dl. Sample 4, initial result gave 6. 5 mg per dl. This result was accompanied by a data flag alerting the use the result was under the normal value limit. Repeat for this sample gave 9. 6 mg per dl. Customer states "she has resolved the problem and does not need service". Customer found the calcium r2 probe blue tip had been partially blocked and styletted out the blue tip, re-primed, recalibrated and controls now in range, which has improved the performance of the assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-06236 |
| MDR Report Key | 1502904 |
| Report Source | 05,06 |
| Date Received | 2009-09-18 |
| Date of Report | 2009-09-18 |
| Date of Event | 2009-09-03 |
| Date Facility Aware | 2009-09-04 |
| Report Date | 2009-09-04 |
| Date Mfgr Received | 2009-09-04 |
| Date Added to Maude | 2009-12-17 |
| 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 D MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Product Code | JFP |
| Date Received | 2009-09-18 |
| Model Number | D MODULE |
| Catalog Number | 03449866001 |
| 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 |