MAUDE Adverse Event Report: WALLAC OY PANTHERA-PUNCHER 9; PANTHER PUNCHER

Model Number 2081-0010

Device Problems Nonstandard Device (1420); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2014

Event Type  malfunction  

Event Description

Through a customer complaint reported on (b)(6) 2014, we became aware that extended exposure in close proximity to the ionizer pins of the panthera-puncher 9 can decrease the reaction signal level of assays using antibody coated microtiter plates (such as those used for immunoassays).No false negative or false positive results are known to have been reported.

Manufacturer Narrative

Our investigation has shown that the ionizer may decrease the reaction signal level of assays using antibody coated plates (such as those used for immunoassays).We have also found that uncoated plates (such as those used for enzymatic assays) are not affected by the phenomenon.The phenomenon has been determined to be localized to wells located beneath or adjacent to wells beneath the ionizer pins when the panthera-puncher 9 is idle or in sleep mode.Our investigation into the phenomenon has determined contributing factors to be the position of the plate beneath the ionizer, the period of time the plate is stationary beneath the ionizer and the voltage of the ionizer unit.The software currently allows the ionizer to remain active when the puncher is idle or has gone into sleep mode.Under these certain conditions the ionizer may negatively impact samples results.

• Brand Name: PANTHERA-PUNCHER 9
• Type of Device: PANTHER PUNCHER
• Manufacturer (Section D): WALLAC OY; turku ; FI
• Manufacturer Contact: ann-christine fagerstrom ; mustionkatu 6; turku 20101 ; FI 20101 ; 3582267812
• MDR Report Key: 3925175
• MDR Text Key: 15121674
• Report Number: 8043909-2014-00001
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2081-0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2014
• Initial Date FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1