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

Model Number	2701
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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.Based upon the customer complaint information, this complaint was not identified as a potential mdr upon receipt, however investigation of the returned device indicates that a report should be made.This report is being submitted at this time based upon the results of the investigation of the returned analyzer.
Event or Problem 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
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 7736 zionsville road; indianapolis IN 46278
• MDR Report Key: 9557354
• Report Number: 1836135-2020-00001
• Device Sequence Number: 1691075
• Product Code: CGA
• UDI-Device Identifier: 00381932701013
• UDI-Public: (01)00381932701013(8012)112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2701
• Device Catalogue Number: 2701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1