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 2017-07-31 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[81524761]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[81524762]
The customer stated that they received an erroneous result for one patient sample tested for the elecsys testosterone ii assay (testo) on a cobas 6000 e 601 module (e601). The sample (collected on (b)(6) 2017) initially resulted as 8. 72 ng/dl and this was reported outside of the laboratory. The physician asked for the sample to be repeated. Before repeating, the sample was re-centrifuged. The sample was repeated on a different e601 analyzer on (b)(6) 2017, resulting as 356. 0 ng/dl. The sample was also repeated on the original e601 analyzer on (b)(6) 2017, resulting as 340. 6 ng/dl. The repeat results were believed to be correct. The patient was not physically hurt during the event and did not receive any care based on the erroneous result. No adverse events were alleged to have occurred with the patient. The testo reagent lot number was 191053. The reagent expiration date was asked for, but not provided. The field service engineer found that there was an issue with a nozzle box assembly. He replaced the assembly. He replaced the sample probe and checked voltage. He adjusted the main pump and gear pump pressures to specifications. He adjusted the rinse stations and checked the external rinse. He adjusted the probes. He ran performance testing and precision studies. Performance testing passed within specifications. All controls were acceptable to the customer. The system was working within specifications. The field service engineer ran precision studies using the same tubes that were used for patient testing. The volume of the sample was approximately 2 ml and there was a small red cell button observed at the bottom of the sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01566 |
| MDR Report Key | 6753319 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-31 |
| Date of Report | 2017-08-13 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-07-12 |
| Date Added to Maude | 2017-07-31 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | CDZ |
| Date Received | 2017-07-31 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 | 2017-07-31 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 | 2017-07-31 |