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 2017-06-30 for EVO ANALYTICAL P MODULE 05023548001 manufactured by Roche Diagnostics.
[78982829]
Patient Sequence No: 1, Text Type: N, H10
[78982830]
The customer stated that they received an erroneous result for one patient sample tested for crpl3 tina-quant c-reactive protein gen. 3 (crp) on an analytical p module analyzer (modp). The erroneous result was reported outside of the laboratory. The sample initially resulted as 254. 15 mg/l accompanied by a data flag. The sample was automatically repeated by the analyzer at a times 2 dilution, resulting as 15. 13 mg/l; this result was reported outside the laboratory. The sample was repeated on a cobas 8000 analyzer, resulting as 244. 83 mg/l accompanied by a data flag. The sample was diluted and repeated on the cobas 8000 analyzer, resulting as 220. 46 mg/l. The repeat value from the cobas 8000 analyzer was believed to be correct. The patient was not adversely affected. The crp reagent lot number and expiration date were asked for, but not provided. The field service engineer determined that the customer pooled the acid wash system reagent into the saline diluent. He replaced the saline diluent with a new bottle. He ran precision studies and these passed. The customer ran calibration and quality controls; these passed. The customer ran dilution comparisons with other roche analyzers and these were good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01376 |
| MDR Report Key | 6680178 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-30 |
| Date of Report | 2017-07-24 |
| Date of Event | 2017-06-04 |
| Date Mfgr Received | 2017-06-04 |
| Date Added to Maude | 2017-06-30 |
| 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 | EVO ANALYTICAL P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2017-06-30 |
| Model Number | P MODULE |
| Catalog Number | 05023548001 |
| 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 | EVO ANALYTICAL P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-30 |
| Model Number | P MODULE |
| Catalog Number | 05023548001 |
| 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 | 2017-06-30 |