MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ACCELERATOR APS; AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM

Catalog Number 07L32-01

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that the architect analyzer generated sample presentation and sample queue errors on a patient sample ((b)(4)) on the ams (omnilab middleware) but not on the architect analyzer.The architect took sample from one tube while a different tube was expected to be sampled and the results did not go to exceptions.The results generated were for folate - initial 6.9 / repeat 3.3.There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

An evaluation was performed by reviewing the complaint text, other customer complaints for similar issues, review of labeling, and review of historical data.Error code 8276 sample presentation error was reported to have occurred on architect system (b)(4).Review of logs by omnilab (manufacturer of the ams middleware) noted that one of the architect instruments sent error 8276 for sample (b)(4), and ams rules properly managed the error.Sample presentation (spe) and sample queue (sqe) error was generated on (b)(4) (folate test) on the aps i2000sr interface module a week later.The error was seen in the ams middleware only, no error was found in the message history of architect (b)(4) or in the aps history.When a sample moves into position for testing, the sample carrier id is read, tests are aspirated, and the carrier id is read again before the sample is released.If the initial and final reads do not match, the first sample generates the presentation error and the second sample generates the queue error.These errors are generated by the aps system.Sample presentation errors due to error code 8275 / 8276 are generated by the architect.These errors occur as a result of issues with the communication between the aps and architect systems.Field service replaced a motor, part number 8-203835-01, which intermittently forced pucks past the sample gate to address the issue.No issues with the aps could be identified.The result log for architect i2000sr sn (b)(4) confirmed that (b)(4) was run on (b)(6) 2015 at 13:57 and 18:10, no error messages were associated with the sample and no errors were found in the history log.A review of ticket history for the analyzer did not identify any issues that may have contributed to the current complaint.There was no trend identified for motor, part number 8-203835-01, or for the aps system related to this issue.A review of the architect and aps operations manuals describes probable causes and corrective actions for spe and sqe errors.A review of complaints for the occurrence of spe/sqe errors or error code 8275/8276, found the errors were addressed by replacing or adjusting various parts and rerunning samples as necessary.Based on the available information, a deficiency was not identified.Error messages were properly generated to alert the operator.

• Brand Name: ACCELERATOR APS
• Type of Device: AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5330646
• MDR Text Key: 35031815
• Report Number: 1628664-2015-00338
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07L32-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1