MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-15 for ANALYTICAL P MODULE 03284549001 manufactured by Roche Diagnostics.
[93221756]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93221757]
The customer questioned multiple results for dialysis patients tested for urea/bun kinetic uv assay for urea/urea nitrogen (urea/bun) on a modular p instrument. Data was provided for 108 patient samples. Of this data, 14 patient samples were erroneous. The erroneous results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The lot number of the reagent was 27324901 with an expiration date of 31-aug-2018. The customer? S quality control results were scattered quite a bit and coefficient of variation (cv) results were not good. The field service engineer (fse) visited the customer site and found that the mixer and halogen bulb were defective. The fse replaced reagent and sample probes. Gear pump pressure was checked. All cv results from hardware performance checks were back within range. No more erroneous results were produced. The investigation determined that the mechanical failure of the mixer and halogen bulb found by the fse was most likely the root cause of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02610 |
| MDR Report Key | 7032511 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2017-10-27 |
| Date Added to Maude | 2017-11-15 |
| 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 | 0 |
| 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 P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-11-15 |
| Model Number | P MODULE |
| Catalog Number | 03284549001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-15 |