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 2018-09-17 for COBAS E 411 IMMUNOASSAY ANALYZER E411 DISK 4775279001 manufactured by Roche Diagnostics.
[120731919]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120731920]
The customer stated that they received erroneous results for one patient sample tested with the elecsys hcg + beta test system (hcgb) on a cobas e 411 immunoassay analyzer. Test results were not accurate when diluting the sample. No erroneous results were reported outside of the laboratory. No units of measure were provided for the hcgb assay. The sample was diluted 1:20, initially resulting as 549. 3. The sample was repeated, resulting as > 10000. The sample was then diluted 1:20 and repeated two more times, resulting as 50650 and 22166. The pipettor assembly of the analyzer was found to be not vertical. The pipettor assembly was adjusted. After the adjustment, the sample was diluted and then repeated 7 additional times, resulting with the following values: 92803 (1:20 dilution); 86397 (1:20 dilution); 50650 (1:20 dilution); 93955 (1:20 dilution); 90503 (1:10 dilution); 86953 (1:10 dilution); 83033 (1:10 dilution). The analyzer was then cleaned using a 3% perhydrol solution. After cleaning, the sample was then diluted 1:20 and three additional times, resulting with values of 94636, 96044, and 95604. No adverse events were alleged to have occurred with the patient. The quality control results were normal. The instrument now works normally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03163 |
| MDR Report Key | 7881257 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-17 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-09-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | COBAS E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2018-09-17 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-09-17 |