MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-09-29 for COBAS 8000 E 801 MODULE E801 07682913001 manufactured by Roche Diagnostics.
[87758853]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[87758854]
The customer received questionable low elecsys brahms pct (procalcitonin) results for two patients. Patient 1 initial result was 0. 483 ng/ml and the repeat result was 4. 31 ng/ml. On (b)(6) 2017, patient 2 initial result was 1. 25 ng/ml and the repeat result was 2. 29 ng/ml. The repeat results were reported outside of the laboratory. There was no allegation of an adverse event. The reagent lot number was 204084. The expiration date was requested but was not provided. Based on the information provided, the customer did not perform good preanalytical handling of the sample including insufficient centrifugation, no sample mixing (tube inversions), and a very low sample draw volume. These are potential causes for erroneous low results. Other typical causes for this type of event include issues with sample quality or insufficient maintenance of the analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02152 |
| MDR Report Key | 6903849 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-08 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-09-29 |
| 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 801 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | PMT |
| Date Received | 2017-09-29 |
| Model Number | E801 |
| Catalog Number | 07682913001 |
| 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 801 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-29 |
| Model Number | E801 |
| Catalog Number | 07682913001 |
| 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 | 2017-09-29 |