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 2017-07-28 for ANALYTICAL P MODULE 03738965001 manufactured by Roche Diagnostics.
[81418809]
Unique identifier (udi)#: na.
Patient Sequence No: 1, Text Type: N, H10
[81418810]
The customer stated that they received erroneous results for two patient samples tested for phos inorganic phosphorus (phos) on an analytical p module (modp) analyzer. The erroneous results were not reported outside of the laboratory and the repeat results were believed to be correct. The first sample initially resulted as 5. 8 mg/dl. When repeated on a different analyzer, the result was 1. 2 mg/dl. The second sample initially resulted as 5. 2 mg/dl. When repeated on a different analyzer, the result was 1. 2 mg/dl. The patients were not adversely affected. The phos r1 reagent lot number was 147818. The phos r3 reagent lot number was 155899. The reagent expiration dates were asked for, but not provided. The field service engineer determined that the analyzer was not washing and tubing was broken. He repaired the broken tubing. The account ran calibration and controls; all were within specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01558 |
| MDR Report Key | 6750110 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-28 |
| Date of Report | 2017-08-13 |
| Date of Event | 2017-07-07 |
| Date Mfgr Received | 2017-07-10 |
| Date Added to Maude | 2017-07-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CEO |
| Date Received | 2017-07-28 |
| Model Number | P MODULE |
| Catalog Number | 03738965001 |
| 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 P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-28 |
| Model Number | P MODULE |
| Catalog Number | 03738965001 |
| 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 | 2017-07-28 |