MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number 03L79-31

Device Problem High Readings (2459)

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

Event Date 07/13/2018

Event Type  malfunction  

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 the customer.

Event Description

The customer reported falsely elevated calcium results on two patients generated on the architect analyzer.The results provided were: pt#1 on 13jul2018 ca =14.5 / repeated x2 = 10.2 / 10.0mg/dl (normal range = 7.9-10.7mg/dl).There was no reported impact to patient management.

Manufacturer Narrative

The calcium assay was removed as a cause of the customer's issue on 08august2018.The architect c4000 analyzer remains as the potential cause reported under mdr # 1628664-2018-01270 and all further information will be documented under that mdr number.Based upon this new information, this complaint is no longer a reportable event.

• 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: 7754501
• MDR Text Key: 116239622
• Report Number: 1628664-2018-01257
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2018
• Device Catalogue Number: 03L79-31
• Device Lot Number: 45322UN17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1