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 2017-04-14 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK 04775201001 manufactured by Roche Diagnostics.
[72847646]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72847647]
The customer complained of an erroneous negative result for 1 patient sample tested for elecsys probnp ii immunoassay (probnp ii) on a cobas e 411 immunoassay analyzer. It is not known if the erroneous result was reported outside of the laboratory. The initial probnp ii result was 67. 12 pg/ml which is negative at this customer site. The last result for this patient was >1,000 pg/ml. The customer repeated the sample that produced the result of 67. 12 pg/ml and the result was 1398 pg/ml. The customer thinks the repeat result is correct. There was no allegation that an adverse event occurred. The probnp ii reagent lot number was 209223 with an expiration date of 05/31/2018. The customer? S centrifugation time is 5 minutes at 3000 rpm; depending on the tube manufacturer, this time may be too short. The customer? S clotting time is 15 minutes; depending on the tube manufacturer, this time may be too short. No issues were identified during a review of the customer? S calibration and quality control data. There is no indication of a general instrument or reagent issue. A specific root cause could not be identified for this event. Additional information was requested for investigation but was not provided. A possible root cause may be related to a pre-analytical issue since the customer? S centrifugation and clotting time may be too short. An additional root cause may be related to insufficient maintenance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00778 |
| MDR Report Key | 6493696 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-14 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-04-14 |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NBC |
| Date Received | 2017-04-14 |
| Model Number | E411 RACK |
| Catalog Number | 04775201001 |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-14 |
| Model Number | E411 RACK |
| Catalog Number | 04775201001 |
| 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 | 2017-04-14 |