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 2016-10-27 for COBAS 6000 E 601 MODULE E601 manufactured by Roche Diagnostics.
[58535031]
(b)(4). The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[58535032]
The customer complained of questionable results for one patient sample tested with the elecsys ca 15-3 ii assay. The sample was initially tested (b)(6) 2016 at 11:16 am with a result of 40. 42 u/ml. That evening the quality controls failed. On (b)(6) 2016 the sample was tested 3 times with results of 22. 09, 21. 91, and 24. 92 u/ml. Results of about 22 u/ml were reported outside the laboratory. Since the patient had previous results of 40 u/ml and 30. 36 u/ml the customer tested a sample from the patient drawn on (b)(6) 2016. The ca 15-3 result was 40 u/ml. The patient was not adversely affected. The ca 15-3 reagent lot number was 152800; the expiration date was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[61419469]
The sample from (b)(6) 2016 was sent to the manufacturer for testing. Testing was performed by the manufacturer on 2 analyzers and replicated the customer's results. The investigation determined no quality controls were performed on 10/13/2016. The investigation was unable to determine the root cause of the event. Inadequate sample preparation of the 10/13/2016 sample, leading to incomplete clotting or microclots, is a possible cause of the lower results in the (b)(6) 2016 sample. A general product problem was excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01648 |
| MDR Report Key | 6060826 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-27 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-10-12 |
| Date Mfgr Received | 2016-10-14 |
| Date Added to Maude | 2016-10-27 |
| 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 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LTK |
| Date Received | 2016-10-27 |
| Model Number | E601 |
| Catalog Number | ASKU |
| 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 | COBAS 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-10-27 |
| Model Number | E601 |
| Catalog Number | ASKU |
| 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 | 2016-10-27 |