MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT INTACT PTH

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false elevated architect intact pth result for a patient.The patient sample generated an initial result of 201 pg/ml and repeated a result of 30 pg/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from arhcitect ipth, list number 08k25-29, and abbott gmbh manufacturing site to architect i1000sr, list number 01l86-40, and abbott laboratories, irving, texas as the manufacturing site.Mdr number 3016438761-2020-00252-00 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer reported a false elevated architect intact pth result for a patient.The patient sample generated an initial result of 201 pg/ml and repeated a result of 30 pg/ml.There was no impact to patient management reported.

• Brand Name: ARCHITECT INTACT PTH
• Common Device Name: INTACT PTH
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10537541
• Report Number: 3002809144-2020-00926
• Device Sequence Number: 14120840
• Product Code: CEW
• UDI-Device Identifier: 00380740156244
• UDI-Public: 00380740156244
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: N/A
• Device Catalogue Number: 08K25-29
• Device Lot Number: 08919I000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR INTGR, 01L86-40, (B)(6) ; ARCHITECT I 1000SR ANALYZER,; LIST 01L86-40, SERIAL (B)(6)