MAUDE Adverse Event Report: PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number 2700

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

The customer reported receiving high control results that were outside the control range when testing eglu.There were no allegations of patient/user harm.The investigation concludes that an internal electrical defect was found, affecting only the amperometric port of the device.This complaint was not identified as a potential mdr upon receipt, however testing of the returned device indicates that a report should be made.Therefore, this report is being submitted, although it is past the 30 day time limit.

Event Description

The customer reported receiving high control results that were outside the control range when testing eglu.There were no allegations of patient/user harm.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 7736 zionsville road; indianapolis IN 46278
• Manufacturer (Section G): PTS DIAGNOSTICS; 7736 zionsville road; indianapolis IN 46278
• Manufacturer Contact: brandon unruh ; 7736 zionsville road; indianapolis, IN 46278 ; 3178705610
• MDR Report Key: 8539954
• MDR Text Key: 145656277
• Report Number: 1836135-2019-00043
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00381932700016
• UDI-Public: (01)00381932700016(8012)111
• Combination Product (y/n): N
• PMA/PMN Number: K140068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2700
• Device Catalogue Number: 2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 03/06/2019
• 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