MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number 03L79-21

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.There were no returns available from the customer site for this evaluation.The architect clin chem calcium assay package insert and the architect system operations manual contain information to address the current customer issue.Customers must follow manufacturer's instructions for both tubes and centrifuges.Serum and plasma samples, if not spun according to manufacturer's specifications, may generate inaccurate values.A review of manufacturing documents verified that all specifications for this assay lot passed.Based on the results of this evaluation and the information from the customer site, a product malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, no systemic issue or product deficiency was identified.Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.

Event Description

The customer reports that one patient sample ((b)(6)) generated an initial clin chem calcium assay result of 3.70 mmol/l on an architect c4000 analyzer on (b)(6) 2016.The sample retested at 2.41 mmol/l.Controls remained within specifications.No suspect results were reported from the lab.There is no impact to patient management reported.Other parameters provide by the customer for this patient: chloride: 105 mmol/l; potassium: 4.0 mmol/l; sodium: 141 mmol/l; glucose: 95 mg/dl; total bilirubin: 0.35 mg/dl; crp: 0.23 mg/dl; alkaline phosphatase: 70 u/l; creatinine; 0.83 mg/dl; ldh: 180 u/l; ast: 28 u/l; ggt: 14 u/l; alt: 20 u/l.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6550806
• MDR Text Key: 74663101
• Report Number: 1628664-2017-00189
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K981578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Catalogue Number: 03L79-21
• Device Lot Number: 36677UN15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER LN: 02P24-40; SN: (B)(4)