MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-IGM IGM ANTI-HAV

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 06c30 that has a similar product distributed in the us, list number 6l21. Patient identifier: sid (b)(6).

Event Description

The customer observed a false nonreactive architect (b)(6) for a patient. On (b)(6) 2020 sid (b)(6) generated an initial result
=
0. 84. S/co (grayzone); repeat result
=
0. 77 s/co (nonreactive); on (b)(6) 2020 repeat result
=
0. 93 s/co (grayzone). The sample was sent (b)(6) hospital for confirmation and generated a reactive result on an architect i2000sr analyzer. On (b)(6) 2020 the customer provided additional patient information: on (b)(6) 2020 sid (b)(6)
=
initial result
=
0. 81 s/co (grayzone), repeat results
=
0. 77 s/co (nonreactive), 0. 93 s/co (grayzone), (b)(6) hospital for confirmation
=
reactive.

• Brand Name: ARCHITECT HAVAB-IGM
• Type of Device: IGM ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10468862
• MDR Text Key: 232785925
• Report Number: 3002809144-2020-00875
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/09/2020
• Device Model Number: N/A
• Device Catalogue Number: 06C30-27
• Device Lot Number: 14088BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown