MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-15 for MODULAR ANALYTICS CORE MODULAR CORE 03739198001 manufactured by Roche Diagnostics.
[15159621]
Customer states she received erroneous results for sodium and she reran over 20 samples. She provided only the following 3 patient results: patient 1, original result 134, repeat 140mmol per l. Patient 2, original result 126, repeat 140 mmol per l. Patient 3, original result 134, repeat 149 mmol per l. Customer states none of the erroneous results were released to physicians for treatment.
Patient Sequence No: 1, Text Type: D, B5
[15170196]
The field service representative determined a defective sipper nozzle was the cause of the discrepancies and he replaced the sipper nozzle. He also replaced syringe seals, performed ise system cleaning and cleaned vacuum line. He performed ise check and ran calibration and controls to verify analyzer operation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2009-04949 |
| MDR Report Key | 1480609 |
| Report Source | 05,06 |
| Date Received | 2009-07-15 |
| Date of Report | 2009-07-15 |
| Date of Event | 2009-06-30 |
| Date Facility Aware | 2009-06-30 |
| Report Date | 2009-06-30 |
| Date Mfgr Received | 2009-06-30 |
| Date Added to Maude | 2009-10-27 |
| 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 | 3 |
| 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 | MODULAR ANALYTICS CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Product Code | MZU |
| Date Received | 2009-07-15 |
| Model Number | MODULAR CORE |
| Catalog Number | 03739198001 |
| 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 | 2009-07-15 |