MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-07 for ANALYTICAL D MODULE 03739023001 manufactured by Roche Diagnostics.
[82722205]
Na.
Patient Sequence No: 1, Text Type: N, H10
[82722206]
The customer received questionable high results for hdl-c plus 3rd generation for two patient samples. The customer runs qc every hour and when it was out of range, they repeated an unknown number of patient samples on another modular system. The results for two patient samples did not agree with the original values. Patient 1 initial result was 69 mg/dl and the repeat result was 43 mg/dl. Patient 2 initial result was 73 mg/dl and the repeat result was 44 mg/dl. The initial results were reported outside the laboratory. The repeat result was believed to be correct and corrected reports were sent. The patients were not adversely affected. The reagent lot numbers and expiration dates were requested but were not provided. The field service representative found the concentrated waste lines of rinse station were clogged causing a fluid failure. He replaced the waste tubing lines, cleaned the rinse station probes, and replaced the reaction cells. He ran calibration and qc with results within specifications. A query performed found no past issues of this nature on any like instruments for the last 12 months at this site. No abnormal trend was identified
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01634 |
| MDR Report Key | 6771610 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-07 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-07-18 |
| Date Added to Maude | 2017-08-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| 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 | ANALYTICAL D MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LBS |
| Date Received | 2017-08-07 |
| Model Number | D MODULE |
| Catalog Number | 03739023001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | ANALYTICAL D MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-07 |
| Model Number | D MODULE |
| Catalog Number | 03739023001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-07 |