MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
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.There is no further patient information provided by customer due to privacy issues.
Event or Problem Description
The customer reported falsely elevated calcium results on one patient.The initial sample was drawn at the physicians site: sample from (b)(6) 2018 (b)(6) on (b)(6) 2018 ca = 4.26 / 4.16 / 4.05 / 3.9 mmol/l(2.23-2.5 mmol/l).The results were reported and the patient was sent to the emergency room where a new sample was drawn: (b)(6) ca = 2.37.The original (b)(6) was repeated on (b)(6) 2018 ca = 2.4; on (b)(6) 2018 different tube same draw (b)(6) ca run 21x and the results ranged from 1.91 to 2.06.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of the architect system, serial number (b)(4), result log with data from the (b)(6) 2018 found (b)(4) was present in the log and all quality control results for that timeframe were within expected ranges.Based on the complaint data and the log review, a possible cause for the erratic results for the calcium assay is the sample preparation for this one patient.Any fibrin strands, particulates or bubbles in the sample can impact the results.Return testing was not completed as returns were not available.A review of complaints found no additional complaints for this issue and no trends were identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and is adequate to advise the customer on the proper sample handling procedures and alert them to possible impact to results if the sample is not properly prepared.Based on the investigation no product deficiency was identified for the clin chem calcium, list number 03l79-21, lot 98314un17.
Additional Manufacturer Narrative
A review of the architect, serial number (b)(4), result log with data from (b)(6) 2018 was attempted, but the sample identification provided in the complaint text was not present in the log.A search of abbottlink found an additional architect at this customer site, serial number (b)(4), and a review of the result log for (b)(6) 2018 from this instrument also failed to locate the expected sample.Based on the complaint data and the log review, a possible cause for the erratic results for the calcium assay is the sample preparation for this one patient.Any fibrin strands, particulates or bubbles in the sample can impact the results.Return testing was not completed as returns were not available.A review of complaints found no additional complaints for this issue and no trends were identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and is adequate to advise the customer on the proper sample handling procedures and alert them to possible impact to results if the sample is not properly prepared.Based on the investigation no product deficiency was identified for the clin chem calcium, list number 03l79-21, lot 98314un17.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7710691
• Report Number: 1628664-2018-00362
• Device Sequence Number: 10950633
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2018

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: 02/27/2019
• Device Catalogue Number: 03L79-21
• Device Lot Number: 98314UN17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/24/2018; 09/07/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/06/2018; 09/10/2018
• 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: ARCHITECT C8000 SYSTEM, LIST # 01G06-01,; ARCHITECT C8000 SYSTEM, LIST # 01G06-01,; ARCHITECT C8000 SYSTEM, LIST # 01G06-01,; SERIAL # (B)(4); SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT C8000 SYSTEM, LIST # 01G06-01,; SERIAL # (B)(4)