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 2017-08-10 for ANALYTICAL D MODULE 03739023001 manufactured by Roche Diagnostics.
[83030376]
Na.
Patient Sequence No: 1, Text Type: N, H10
[83030377]
The customer questioned high results for patients tested for hdl-c plus 3rd generation (hdl-c) and low results for patients tested for co2-l bircarbonate liquid (co2-l) on a modular analytics d-module. Data was provided for 4 patient samples. The results for 2 patient samples tested for hdl-c were erroneous. The erroneous results were not reported outside of the laboratory. Patient 1 initial hdl-c result from the d-module was 144 mg/dl. The sample was repeated on a p-module and the result was 42 mg/dl. Patient 2 initial hdl-c result from the d-module was 149 mg/dl. The sample was repeated on a p-module and the result was 42 mg/dl. The repeat results were believed to be correct. No adverse event occurred. The customer declined to provide any additional information related to this event. The hdl-c reagent lot number and expiration date were not provided. The field service engineer (fse) visited the customer site and identified some nozzle issues. A high concentration waste rinse nozzle was leaking and there was an unsecured clip for the cell blank nozzles. The fse cleaned the high concentration waste flow path and valves. The clip was secured for the cell blank nozzle on the rinse arm assembly. Mechanism checks were run to make sure no further leaks occurred. The customer ran calibrations and quality controls and the results were acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01669 |
| MDR Report Key | 6784051 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-10 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-07-21 |
| Date Mfgr Received | 2017-07-21 |
| Date Added to Maude | 2017-08-10 |
| 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 | 2017-08-10 |
| Model Number | D MODULE |
| Catalog Number | 03739023001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-08-10 |
| Model Number | D MODULE |
| Catalog Number | 03739023001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-10 |