MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS INTACT PTH; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Model Number	A16972
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is case (b)(4).The customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.The access pth reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.No other patient results were called into question.The customer did not report an issue with the sample integrity.As the customer reported that the staff checks the sample to ensure it is within 24 hours from booking in, it was recommended to customer to follow the intact pth instructions for use part number a57353 n stating: ¿for serum samples: store samples tightly stoppered at room temperature (15 to 30°c) for no longer than 4 hours.¿ in conclusion, the cause of this event cannot be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
Event or Problem Description
On (b)(6) 2021 the customer reported one non-repeatable erroneously elevated pth (access intact pth) result had been generated on the customer's unicel dxi 800 immunoassay system (part number 973100 and serial number (b)(4)).The patient¿s pth result obtained on (b)(6) 2021 was high at 114.9 pg/ml and discordant with the patient clinical file (expected values are 12-88 pg/ml).Then the patient¿s supplementation in calcium was stopped on (b)(6) 2021 and the patient was retested twice.The pth results were at 56.8 pg/ml on (b)(6) 2021 and at 39.7 pg/ml on (b)(6) 2021.As the last result was as expected, the treatment was restarted on (b)(6) 2021.The patient had a normal adjusted calcium and renal function and was vitamin d supplemented.The patient is suffering from osteoporosis, the additional patient¿s supplementation in calcium was temporarily stopped by the rheumatologist after the elevated pth result was obtained.The treatment was stopped on (b)(6) 2021 then restarted on (b)(6) 2021.There was no further report of an injury or illness to the patient attributable to the output from the device in this event.No hardware errors or other assay issues were reported in conjunction with this event.System check passed on 8oct2021 and on 19oct2021.Calibration passed on (b)(6) 2021 with reagent lot 172064 and calibrator lot 189735.Qc was passing within the laboratory¿s established ranges at time of the event.No issues with sample integrity were reported by the customer.Per customer verbal's report, samples are booked in on receipt, centrifuged and placed on the automate for sorting before it goes on to the main analyzer.The staff check the sample to ensure it is within 24 hours from booking in.The sample was not hemolyzed.A sarstedt serum gel tube was used to collect the sample, the tube was centrifuged at 3600 rpm for 10 minutes.The clot time is unknown.It is unknown if the tube was completely filled.

• Brand Name: ACCESS INTACT PTH
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer (Section G): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 13017280
• Report Number: 9680746-2021-00053
• Device Sequence Number: 4976616
• Product Code: CEW
• UDI-Device Identifier: 15099590201937
• UDI-Public: (01)15099590201937(17)220331(11)210331(10)172064
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: A16972
• Device Catalogue Number: A16972
• Device Lot Number: 172064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female