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 2018-03-12 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[102446330]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[102446331]
The customer stated that they received erroneous results for one patient sample tested for the elecsys ca 15-3 ii assay (ca 15-3) on the cobas 6000 e 601 module (e601). The sample initially resulted as 30. 08 u/ml. On (b)(6) 2018, the test was calibrated and control results were within range. The sample was then repeated on (b)(6) 2018, resulting as 32. 51 u/ml. The 32. 51 u/ml value was reported outside of the laboratory. The results was considered to be too high by the physician, so the sample was sent to another laboratory for testing on a cobas 8000 e 602 module (e602). The result from the e602 analyzer was 24 u/ml. The sample was tested a third time on the customer's e601 analyzer on (b)(6) 2018, resulting as 33. 16 u/ml. No adverse events were alleged to have occurred with the patient. The first sample measurement performed on the e601 analyzer was measured with ca 15-3 reagent lot number 187902. The second and third sample measurements performed on the e601 analyzer were measured with ca 15-3 reagent lot number 209900. The reagent expiration dates were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00758 |
| MDR Report Key | 7330272 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-12 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-02-14 |
| Date Mfgr Received | 2018-02-21 |
| Date Added to Maude | 2018-03-12 |
| 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 |
| 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 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | MOI |
| Date Received | 2018-03-12 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 | 2018-03-12 |