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Catalog Number 02K91-23
Device Problem High Test Results (2457)
Patient Problem No Code Available (3191)
Event Date 01/18/2016
Event Type  Injury  
Manufacturer Narrative
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4).
Event Description
The customer observed a falsely elevated ca19-9 result on the architect i2000sr analyzer. The following data was provided: initial 88 u/ml, repeat 115 u/ml, 118 u/ml. Data from another method was also included: 8 u/ml and 9 u/ml on roche method and 9 u/ml and 9 u/ml on diasorin method. The female patient was referred to the hospital for imaging studies and an endoscopy. The imaging studies were normal and showed no signed of cancer. No further patient details were able to be obtained.
Manufacturer Narrative
A returned patient sample was provided by the customer and specificity testing was conducted with the suspect medical device. Two different studies were conducted on the sample. First, of the manual dilutions prepared, one of the three dilutions indicated evidence of a potential interferent. Second, when the returned sample was treated with a heterophilic blocking tube (hbt), the results of the testing indicates the interference was due to heterophilic antibodies. Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, and accuracy testing. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications. Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.
Manufacturer Narrative
The conclusion code was corrected to (b)(4). The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.
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Type of DeviceCA 19-9
Manufacturer (Section D)
100 abbott park road
abbott park IL 60064 3500
Manufacturer (Section G)
100 abbott park road
abbott park IL 60064 3500
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
MDR Report Key5492614
MDR Text Key40114132
Report Number1415939-2016-00037
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date05/03/2016
Device Catalogue Number02K91-23
Device Lot Number50351M500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/10/2016 Patient Sequence Number: 1