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

Lot Number	A219
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting identified that the customer did not perform check strip (quality check) on the analyzer prior to testing.During troubleshooting, the check strip test failed which indicates the analyzer should not be used.The customer returned the analyzer for investigation.The returned analyzer exhibited glucose results within zone b of the glucose consensus error grid however on the lower end thus prompting this incident to be reported out of an abundance of caution.Qc retention was tested and measured well within specification.See medical opinion: with regard to under-recovery of glucose, a small error would not affect any clinical decisions.A large error (even ignoring lack of signs and symptoms of hypoglycemia) would pose no risk to the patient (with the provision of oral carbohydrates).
Event or Problem Description
The customer reported receiving high cholesterol (out of range) and low unbelievable glucose recovery.There were no allegations of patient/user harm.This incident will be reported out of an abundance of caution due to the returned analyzer investigation.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer (Section G): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN ; 3178705610
• MDR Report Key: 17848419
• Report Number: 1836135-2023-00032
• Device Sequence Number: 7173505
• Product Code: CGA
• UDI-Device Identifier: 00381931765016
• UDI-Public: (01)00381931765016(17)231219(10)A219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

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 Expiration Date: 12/19/2023
• Device Lot Number: A219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown