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 2015-09-24 for COBAS 8000 E602 MODULE manufactured by Roche Diagnostics.
[26698966]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[26698970]
The customer reported that they received a complaint from their physician who stated that all of his patients had low recovery for ferritin. It was stated that a total of 60 patient samples were affected. The controls were then repeated for ferritin and it was found that the control recovery was low. The test was then re-calibrated and this calibration passed. Controls were then repeated and were ok. The customer then repeated all samples and reported these repeat results to the physician. Data for a total of 68 patient samples was provided. Of these 68 samples, 55 were found to have erroneous results that were reported outside of the laboratory. Refer to the attachment for the results from these 55 patient samples. For the samples indicated in green, the initial results for these samples were reported outside of the laboratory, but the physician did not see these results. For the samples indicated in yellow, the physician complained about the initial results. The patients were not adversely affected. The ferritin reagent lot number was 181386, with an expiration date of 03/30/2016. Performance testing was performed on the analyzer. Investigations have determined that a general reagent issue could not be seen since all calibrations were within expectations and controls recovery was within specification prior to the event and after re- calibration.
Patient Sequence No: 1, Text Type: D, B5
[31369699]
A specific root cause could not be determined based on the provided information. A malfunction of the analyzer was not found. It is possible that a clot may have caused or contributed to the event since an alarm indicating a clot was seen prior to the measurement of the samples. The customer confirmed that the issue has not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04219 |
| MDR Report Key | 5101714 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-24 |
| Date of Report | 2015-11-16 |
| Date of Event | 2015-09-10 |
| Date Mfgr Received | 2015-09-10 |
| Date Added to Maude | 2015-09-24 |
| 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 8000 E602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2015-09-24 |
| Model Number | NA |
| 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 46250 US 46250 |
| Brand Name | COBAS 8000 E602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-09-24 |
| Model Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-24 |