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 2017-08-14 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[83999454]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83999455]
The customer complained of an erroneous low result for 1 patient tested for elecsys total psa immunoassay (total psa) on a cobas 8000 e 602 module. The erroneous result was not reported outside of the laboratory. The initial total psa result was 0. 112 ng/ml. The sample was repeated and the result was 5. 03 ng/ml. An additional total psa result of 5. 04 ng/ml was provided. It? S not clear if this is an additional repeat result or the result from a new sample. There was no allegation that an adverse event occurred. The total psa reagent lot number was 216023 with an expiration date of 06/30/2018. The customer did not observe any clots or fibrin in the sample. The customer did observe little bubbles on the wall of the sample tube. No issues were identified during a review of the customer? S calibration data. Since the customer observed bubbles on the wall of the sample tube, bubbles or foam on the sample surface may have caused the issue. The field service engineer (fse) visited the customer site and found that the procell aspiration tube filter was loose. Loose procell aspiration tube filters can cause air and system reagent to mix under certain conditions. This can affect results. Usually, when this occurs, multiple results are affected in a row and not just a single result. It cannot be fully excluded that the loose procell aspiration filter was a factor in the low total psa result. A specific root cause was not identified. Additional information was requested for investigation but was not provided. A general product problem has been excluded. The most likely root causes may be related to bubbles on the sample surface or the loose procell aspiration filter identified by the fse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01683 |
| MDR Report Key | 6792567 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-07-24 |
| Date Mfgr Received | 2017-07-24 |
| Date Added to Maude | 2017-08-14 |
| 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 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LTJ |
| Date Received | 2017-08-14 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 |
| Brand Name | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-14 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |