MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for K1367 1260 INFINITY HIGH PERFORMANCE AUTOSAMPLER CLINICAL EDITION K1367E manufactured by Agilent Technologies Manufacturing Gmbh & Co Kg.
[102216193]
We investigated the issue reported, based on our investigation we found that a user error is the root cause of the reported problem. The customer had placed the upper well plate in standard position in the instrument, creating the worklist accordingly but had selected the "back to front orientation" feature for the upper plate configuration, i. E. To denote that the plate is installed at 180 degrees to the standard position. The instrument processed the samples accordingly. The patient assignments per worklist did not match the sample processing order configured.
Patient Sequence No: 1, Text Type: N, H10
[102216194]
It was reported per the customer that the 1260 infinity high performance autosampler k1367e clinical edition did not pick up the samples from the correct well positions. After investigation, the issue was attributed to user error. The customer recalled the incorrect results on (b)(6) 2018 and resubmitted corrected reports on (b)(6) 2018. On (b)(6) 2018, the customer reported that the user error reoccurred. The customer noticed the back to front pipetting sequence for the upper plate and aborted the run. Incorrect results were not released. The customer set up a new run and released the correct results (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916205-2018-00001 |
| MDR Report Key | 7328645 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-08 |
| Device Manufacturer Date | 2017-03-15 |
| Date Added to Maude | 2018-03-09 |
| 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 | MR. KEVIN DRAPER |
| Manufacturer Street | 5301 STEVENS CREEK BLVD |
| Manufacturer City | SANTA CLARA CA 95053 |
| Manufacturer Country | US |
| Manufacturer Postal | 95053 |
| Manufacturer Phone | 4085537327 |
| Manufacturer G1 | AGILENT TECHNOLOGIES GMBH |
| Manufacturer Street | HEWLETT-PACKARD-STRASSE 8 |
| Manufacturer City | WALDBRONN, 76337 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76337 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | K1367 1260 INFINITY HIGH PERFORMANCE AUTOSAMPLER CLINICAL EDITION |
| Generic Name | K1367 1260 INFINITY HIGH PERFORMANCE AUTOSAMPLER CLINICAL EDITION |
| Product Code | KIE |
| Date Received | 2018-03-09 |
| Model Number | K1367E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGILENT TECHNOLOGIES MANUFACTURING GMBH & CO KG |
| Manufacturer Address | HEWLETT-PACKARD-STRASSE 8 WALDBRONN, 76337 GM 76337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-09 |