MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-06-19 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[5851796]
The customer received questionable cortisol results for one patient while performing a method correlation for 18 patients between the cortisol and cortisol ii reagents. The unit of measure was not provided. First testing: cortisol 100. 4 cortisol ii 38. 5 second testing: cortisol 148. 7 cortisol ii 74. 62 third testing: cortisol 161. 2 cortisol ii 96. 86 information concerning if any erroneous result was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided. The cortisol reagent lot number was 185360. The expiration date was requested, but was not provided. The cortisol ii reagent lot number and expiration date were requested, but were not provided.
Patient Sequence No: 1, Text Type: D, B5
[13494811]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[13500246]
Patient Sequence No: 1, Text Type: N, H10
[14249834]
Additional information was received that medwatch field (date received by manufacturer) was actually (b)(4) 2015. The cortisol reagent lot was actually 185380. The cortisol ii reagent lot number was 185360. Samples from the patient were submitted for investigation and the customer's results were confirmed. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
[19259918]
Additional information was provided that the results were generated for a method comparison only. No erroneous results were reported outside the laboratory and no patients were adversely affected.
Patient Sequence No: 1, Text Type: N, H10
[23715736]
A general reagent issue was not suspected based on the provided qc data and the confirmation of the results for the samples when tested during investigation. Differences in the results between the two reagents may be due to the different antibodies used and the standardization. Although the results for a single sample differ between the reagents, the interpretation is comparable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03680 |
| MDR Report Key | 4857055 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-06-19 |
| Date of Report | 2015-08-21 |
| Date of Event | 2015-05-28 |
| Date Mfgr Received | 2015-05-28 |
| Date Added to Maude | 2015-06-19 |
| 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 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NHG |
| Date Received | 2015-06-19 |
| Model Number | NA |
| 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 46250 US 46250 |
| Brand Name | COBAS 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-06-19 |
| Model Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-19 |