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 2017-10-12 for COBAS 8000 E 801 MODULE E801 manufactured by Roche Diagnostics.
[90336413]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90336414]
The customer questioned results for 2 patient samples tested for elecsys brahms pct (pct) on a cobas e 801 module. The customer has had ongoing issues with imprecise pct results. Based on the data provided, the results for 1 patient were erroneous. It is not known if erroneous results were reported outside of the laboratory. The initial pct result from the e801 module was 6. 18 ng/ml. The sample was repeated 4 times on the e801 module with results of 7. 00 ng/ml, 8. 69 ng/ml, 9. 91 ng/ml and 13. 4 ng/ml. The customer sent the sample to an external laboratory and the result was 8. 69 ng/ml. There was no allegation that an adverse event occurred. The pct reagent lot number was 204084. The expiration date was not provided. The customer? S calibration data from 24-aug-2017 does not suggest any issues. The customer? S quality control (qc) results could not be assessed as the lot number was invalid and the results were implausible. The customer uses a sample volume of 0. 7 ml which is much too low for a 4 ml sample tube. The customer does not perform tube inversions. The customer uses a centrifugation time of 5 minutes at 3500 rpm. The relative centrifugal force (rcf) was not provided. The customer? S centrifugation time of 5 minutes may be inadequate as most tubes need a centrifugation time of 5-15 minutes. The customer uses rack adapters. A specific root cause was not identified. Additional information was requested for investigation but was not provided. Potential root causes may be related to the sample volume and other pre-analytical issues such as centrifugation time and the lack of sample mixing. Additional possible root causes may be insufficient electromagnetic interference lab compliance, sample quality, insufficient maintenance, or contamination of the environment with the analyte.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02280 |
| MDR Report Key | 6943823 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-09-22 |
| Date Mfgr Received | 2017-09-26 |
| Date Added to Maude | 2017-10-12 |
| 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 | 0 |
| 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 E 801 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | PMT |
| Date Received | 2017-10-12 |
| Model Number | E801 |
| Catalog Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-12 |