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 2015-08-12 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[25140650]
This event occurred in grc. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25140651]
The customer received questionable ferritin results for one patient. Two serum samples a and b were drawn from the patient. Sample a initial result was 255. 6 ng/ml. This result was unexpected by the customer and they tested sample b with a result of 12. 08 ng/ml. The customer repeated both samples in cups and the results for sample a were 254. 9 ng/ml and 266. 3 ng/ml. The result for sample b was 11. 81 ng/ml. On (b)(6) 2015, the patient was redrawn and the result was 9. 58 ng/ml. This result confirmed the lower results from sample b and fit with the patient's clinical picture of generally feeling unwell. Other assays were repeated for both sample a and b and the results were very similar between the two samples. Information concerning if any result was reported outside the laboratory was requested, but was not provided. The patient was not adversely affected. The reagent lot number was 181386. The expiration date was requested, but was not provided. The field service representative checked the analyzer and did not find any issues. All tests were calibrated and controls performed without problems. A specific root cause could not be determined. Additional information for further investigation was requested, but was not provided. Contamination of sample a was possible. Based on the provided calibration and qc data, a general reagent issue was excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-03955 |
| MDR Report Key | 4996678 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-12 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-07-27 |
| Date Added to Maude | 2015-08-12 |
| 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 | 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 | DBF |
| Date Received | 2015-08-12 |
| Model Number | NA |
| 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 46250 US 46250 |
| Brand Name | COBAS 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-08-12 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |