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 2016-06-20 for COBAS 8000 E602 MODULE 05990378001 manufactured by Roche Diagnostics.
[47748094]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4). The patient age was also provided as (b)(6). A clarification has been requested. The full facility name was provided as (b)(6). Phone number was provided as "(b)(6)".
Patient Sequence No: 1, Text Type: N, H10
[47748095]
The customer stated that they received an erroneous result for one patient sample tested for ferritin on the e602 analyzer. The sample initially resulted as 33. 29 ug/l and this value was reported outside of the laboratory. The result was questioned by the clinician since it did not fit with previous results for the patient. The initial result was also said to not fit a subsequent result. The sample was repeated with an automatic dilution, resulting as 6177 ug/l. The patient was not adversely affected. The ferritin reagent lot number and expiration date were asked for, but not provided. The field service engineer replaced pinch valve tubings and a valve. He also performed preventive maintenance on the analyzer, including running a fishing line through the sipper flow path, reagent probe, and tubing. He performed a "system volume". Controls were run for all assays and these were ok. He found that a fuse was blown and he replaced this, but it blew again. He replaced a printed circuit board within the analyzer.
Patient Sequence No: 1, Text Type: D, B5
[48017063]
The patient's date of birth of (b)(6) 1985 has been confirmed to be correct, so the patient was (b)(6) at the time of the event.
Patient Sequence No: 1, Text Type: N, H10
[49066300]
The result of 6177 g/l was believed to be correct, as the patient has a history of having a high ferritin. A specific root cause could not be determined based on the provided information. The most likely root cause would be related to pre-analytic handling of the sample. A general reagent issue can most likely be excluded. The event was not reproducible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00785 |
| MDR Report Key | 5735619 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-20 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-06-04 |
| Date Mfgr Received | 2016-06-07 |
| Date Added to Maude | 2016-06-20 |
| 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 | 2016-06-20 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-20 |