MAUDE Adverse Event Report: ABBOTT POINT OF CARE MARTEL PRINTER. I-STAT1 ANALYZER

Catalog Number 06F23-91

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).

Event Description

On (b)(6) 2013, abbott point of care was contacted by a customer who reported that a martel printer rechargeable batter became hot to touch when being charged and made the printer warm.The martel printer product number 06f23-91 for the i-stat1 analyzer is currently discontinued.The customer states they ordered a new battery and placed it in the printer and the printer and new battery worked fine.However, the product was replaced and the customer was asked to return the printer, rechargeable battery and cables for investigation.Based on the information available at the time, there were no injuries associated with this event.

Manufacturer Narrative

(b)(4).The investigation was completed on 01/28/2016.The results charging tests did show evidence that the use of the power supply (ps) recieved from the customer.It was determined that the ps returned with the printer, caused the rechargeable battery to reach higher temperatures during recharging as compared to when recharging is performed using proper martel ps.However, the measured surface temperatures from the printer and rechargeable battery were below the test temperature limits, and therefore, not considered hot to touch.The customer's complaint was not reproduced though failure analysis.However, the customer complaint was determined to be caused by use of an incorrect power supply.As per i-stat system manual, art: 714369-00k, rev.Date: 06-apr-15: caution: use only a rechargeable battery pack purchased from abbott (b)(4).Rechargeable battery packs not recommended by or purchased from abbott (b)(4) may be susceptible to overheating and could lead to a potential fire or burn hazard; use power supply provided with printer; do not operate the printer without paper; do not allow the power supply to become a trip hazard; do not disturb the analyzer or printer until printing is complete since this will interrupt the printout.If printing is interrupted, realign the printer and analyzer or replace the analyzer in the downloader to resume printing.Note: if significant time has elapsed, some results may be missing from the printout.Reprint the results; if printed results appear inconsistent with a patient's clinical assessment, verify that the printed results match the data in the analyzer.If the results do match, the patient sample should be retested using another cartridge.If they do not match, reprint the results.If the reprint still does not match the analyzer data, the printer requires service and the printed results must not be used.

• Brand Name: MARTEL PRINTER. I-STAT1 ANALYZER
• Type of Device: MARTEL PRINTER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): MARTEL INSTRUMENTS; durham, england DH9 9 XG; UK DH9 9XG
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 5210061
• MDR Text Key: 31030044
• Report Number: 2245578-2015-00063
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 06F23-91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1