MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HIV AG/AB COMBO; HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES

Catalog Number 02P36-25

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 03/26/2014

Event Type  Injury  

Event Description

The customer stated that the architect analyzer generated (b)(6) results on one patient.The results provided for (b)(6).Patient sample was sent for western blot = (b)(6).On (b)(6) 2014, a new sample was drawn on this patient due to exposure by a hospital employee, and the architect (b)(6) results were again (b)(6).The hospital nurse had a cut on an index finger and was not wearing gloves while she cleaned a dressing on the patient.The cut on the nurse's index finger came into contact with the patient's blood.The nurse requested (b)(6) therapy because of the (b)(6) results generated by the architect, therefore, this is an adverse event.

Manufacturer Narrative

(b)(4).Evaluation: further evaluation of the customer issue included a review of the complaint text, accuracy testing, a search for similar complaints, manufacturing records, and a review of labeling.A retained reagent kit of lot 36077li00 was tested for specificity accuracy.Results of the specificity testing showed normal performance without (b)(6) results for lot 36077li00.A review of complaints determined that there is no unusual activity for lot 36077li00.Review of the product labeling concluded that the (b)(6) results are sufficiently addressed.Manufacturing records were reviewed for lot 36077li00 and there were no issues identified.There is not enough information to reasonably suggest a malfunction, since potential (b)(6) results were obtained for two discreet samples on one patient.Based on the investigation, it has been determined that the product is performing acceptably.

• Brand Name: ARCHITECT HIV AG/AB COMBO
• Type of Device: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 6520 5; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3770201
• MDR Text Key: 17951868
• Report Number: 3002809144-2014-00121
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2014
• Device Catalogue Number: 02P36-25
• Device Lot Number: 36077LI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERIAL # (B)(4); ARCHITECT I1000SR ANALYZER, LIST # 01L86-01,
• Patient Outcome(s): Required Intervention