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 2017-06-09 for COBAS 8000 E 602 MODULE E602 manufactured by Roche Diagnostics.
[77625801]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[77625802]
The customer received questionable high elecsys afp assay results for multiple patient samples and suspected carryover from one sample tested prior to these samples that had a result of >60500 ng/ml. For one patient, the initial result was "80". The doctor doubted the result as it was not consistent with the previous results and clinical symptoms for the patient. As the sample had been discarded, a new sample was drawn from the patient on (b)(6) 2017. The result from the new sample was "1". Specific data for this sample was not provided. Data was provided for six patient samples questioned by the customer based on the previous result for the patient. These samples were discarded and could not be repeated. Data was also provided for one patient sample where the original sample and an additional sample from the day of the event were repeated. Refer to the attachment to the medwatch for all patient data. There was no allegation of an adverse event. The reagent lot number was 120174. The expiration date was requested but was not provided. The investigation reviewed all afp results provided from the day of the event and determined carryover from the high sample was not likely as the samples immediately following this sample did not have elevated results or data flags indicating carryover. Review of the provided calibration and qc data found all were acceptable and in range. Based on the provided data, a general device issue was excluded.
Patient Sequence No: 1, Text Type: D, B5
[117967345]
A specific root cause could not be determined. Possible causes include an issue with the preanalytic handing of the samples. It was recommended to retest the patients with a new sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01197 |
| MDR Report Key | 6630795 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-09 |
| Date of Report | 2017-07-06 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-05-26 |
| Date Added to Maude | 2017-06-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | CDZ |
| Date Received | 2017-06-09 |
| Model Number | E602 |
| 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 |
| Brand Name | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-09 |
| Model Number | E602 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-06-09 |