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 2017-06-02 for COBAS 4000 C (311) STAND ALONE SYSTEM C311 04826876001 manufactured by Roche Diagnostics.
[76666050]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76666051]
The customer complained of an erroneous low result for 1 patient sample tested for crpl3 c-reactive protein gen. 3 (crpl3) on a cobas 4000 c (311) stand alone system. The initial crpl3 result was 0. 00 mg/l with a data flag. The result was reported outside of the laboratory as <1 mg/l. The nurse noticed that this result did not correspond to the patient? S historical results and requested the sample be repeated. The repeat result approximately an hour later was 237. 34 mg/l. The patient was not treated based on the results. No adverse event occurred. The patient has been discharged from the hospital. The crpl3 reagent lot number and expiration date were not provided. The customer said only one sample was affected, they had no issues prior to the event, and as of (b)(6) 2017 had had no further issues. The field service representative (fsr) visited the customer site and noted that water rinse levels were low. These were adjusted. The sample probe was replaced and adjusted. Gear head pump pressure was increased. Quality control results were acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01135 |
| MDR Report Key | 6608557 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-05-02 |
| Date Mfgr Received | 2017-05-12 |
| Date Added to Maude | 2017-06-02 |
| 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 |
| 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 | COBAS 4000 C (311) STAND ALONE SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2017-06-02 |
| Model Number | C311 |
| Catalog Number | 04826876001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | BIOMEDICAL ENGINEER |
| 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 | COBAS 4000 C (311) STAND ALONE SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-02 |
| Model Number | C311 |
| Catalog Number | 04826876001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | BIOMEDICAL ENGINEER |
| 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 | 2017-06-02 |