MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 08H67-01

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the cell-dyn ruby analyzer did not operate.The customer heard a sound and they smelled a burnt odor.Error code 2077 (flow script timeout) was observed.The screen initially displayed, then shut down.The customer disconnected the analyzer from the power outlet.During repair by abbott service fse personnel, a visibly damaged charred component on the vpm board was observed (vacuum pressure supply flow part (b)(4)).No fire or injury was reported.

Manufacturer Narrative

An abbott field service engineer was dispatched to the account and found a visibly damaged charred component on the vpm board (vacuum pressure supply flow part 8960122101) on the cell-dyn ruby analyzer.The vpm board contained a burnt area at the joint of the cr1 cathode and j1, pin1 (positive side of the solenoid).The issue was limited to this part and did not spread to other parts of the equipment.The cell-dyn ruby was repaired and the analyzer was returned to normal operation.Investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, a review of instrument service, and examination of the returned part.Returns were made available from the customer site for this evaluation.Abbott engineers examined the damaged board.The burnt area was due to overheating of the cr2 (1n4003, flyback diode) that was due to arcing and/or voltage spike imposed on cr2.The arcing and/or voltage spike could have been due to either the solenoid cable that connects to j1 being removed while q1 (switching power transistor) was turn on, and the solenoid coil was energized or the solenoid valve was power cycled by the flow script as normal and the cr2 failed to absorb the stored energy dissipated from the coil while q1 was turn off.The driver circuitry was examined and no other issues were found on the same printed circuit board.Cell-dyn ruby analyzer serial number 34641bg service history was reviewed and no contributing factors were found.No subsequent reports of smoke/burn issues were identified.Historical complaint data was reviewed and no adverse trend was identified.Product labeling was reviewed and found to be adequate.The issue was resolved through normal troubleshooting procedures.Based on all available information and abbott diagnostics complaint investigation for the cell-dyn ruby analyzer, no product deficiency was identified.

• Brand Name: CELL-DYN RUBY ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• 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: 5952658
• MDR Text Key: 54794252
• Report Number: 2919069-2016-02138
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061667
• 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: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2008
• 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